Comparison of Three Methods for Anterior Cruciate Ligament Reconstruction

• Sponsor: University of Calgary (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT00529958
• Collaborator: Workers' Compensation Board, Alberta (Other)
• Enrollment: 330
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 171
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this randomized clinical trial is to determine the difference in quality of life outcome at two years, in patients undergoing an Anterior Cruciate Ligament (ACL) reconstruction procedure with either a patellar tendon, quadruple hamstring tendon or a double-bundle hamstring tendon autograft.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Rupture; Deficiency of Anterior Cruciate Ligament; Chronic Instability of Knee; Anterior Cruciate Ligament Injury	Procedure: Patellar Tendon; Procedure: Hamstring Tendon; Procedure: Double-Bundle	N/A

Detailed Description

Following an ACL injury, the knee is predisposed to chronic instability, further damage to the meniscal and chondral structures in the knee, osteoarthritis and an impaired quality of life. The successful treatment of an ACL deficient knee aims to preserve the intact meniscus and chondral structures, and to provide a functionally stable knee so that patients can return to pre-injury activities and restore their quality of life. The current standard of care for ACL deficient knees is with a surgical ACL reconstruction procedure. A Cochrane Review was done and demonstrated that the existing literature is controversial. To date, no existing trial has used validated patient-based outcome assessment, accounted for the critical differences between acute and chronic ACL deficiency or used modern techniques to ensure randomization concealment and a sufficient sample size to avoid type II error. The existing information does not define graft failure or re-ruptures, involve long-term follow-up to address osteoarthritis development, nor compare outcomes between single- and double-bundle reconstructive techniques. The current standard includes either a patellar tendon or quadruple semitendinosus/gracilis tendon autograft reconstruction. The newest option is a double-bundle semitendinosus/gracilis graft. This option attempts to restore the complex ACL anatomy by using two separate tendon components to reconstruct the ACL. This study will measure disease-specific quality of life at short- and long-term post-operative intervals (1, 2, 5 and 10 years). Additional secondary outcomes, including the incidence of traumatic re-ruptures and graft failures, will also be compared between treatment groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial Comparing Three Methods for Anterior Cruciate Ligament Reconstruction: Patellar Tendon, Quadruple Semitendinosus/Gracilis and Double-Bundle Semitendinosus/Gracilis Grafts.
• Actual Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patellar Tendon (PT) ACL reconstruction using a patellar tendon autograft	Procedure: Patellar Tendon; Patellar Tendon autograft; Other Names: Bone-patellar tendon-bone graft BTPB graft
Active Comparator: Hamstring (HT) ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft	Procedure: Hamstring Tendon; Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Names: Single-bundle hamstring graft ST/G graft
Active Comparator: Double-Bundle (DB) ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft	Procedure: Double-Bundle; Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft; Other Names: Double-bundle ST/G graft

Outcome Measures

Primary Outcome Measures

1. Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome [Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively]

   The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.

Secondary Outcome Measures

1. Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures [Minimum 2-year Follow-up, and 5-Year Follow-up]

   COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy. PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy. TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears". ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.

2. Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade [Baseline, 1, 2 and 5 years post-operatively]

   IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).

3. Mean International Knee Documentation Committee (IKDC) Subjective Score [Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively]

   Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.

4. Number of Participants With Each Pivot Shift Grade [Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively]

   The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.

5. Proportion of Patients With Moderate or Severe Kneeling Pain [Baseline, 2 and 5 years post-operatively]

   Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.

6. Knee Laxity as Measured by the KT Arthrometer [Baseline, 1 and 2 years post-operatively]

   Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.

7. Mean Tegner Activity Level [Baseline, 6 months, 1 and 2 years post-operatively]

   Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))

8. Return to Pre-injury Tegner Activity Level [1, 2 and 5 years post-operatively]

   Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).

9. Cincinnati Occupational Rating Scale [Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively]

   The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.

10. Skin-to-Skin Operative Times [During surgery]

    Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure

11. Radiographic (X-ray) Changes [Baseline, 2 and 5 years post-operatively]

    The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.

Other Outcome Measures

1. Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome) [2 years post-operatively]

   All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

A confirmed diagnosis of anterior cruciate ligament deficiency based on all of the following:

• History of a traumatic injury episode

• Physical examination findings of increased anterior translation of the tibia on the femur (Lachman test and/or anterior drawer test)

• A positive pivot shift test

• X-rays showing skeletal maturity (ie: tibial tubercle fused) and no fractures. (NB: Magnetic resonance imaging is not required)

• Age 14-50 years old

Exclusion Criteria:

• Patients with combined ligament deficiencies (Posterior Cruciate, Medial and/or Lateral Collateral deficiency.) (NB: Grade 1 side to side differences (ie. < 5mm) on valgus, varus or posterior stress testing will not be considered exclusions)

• Intra-operative identification of International Cartilage Repair Society (ICRS) Grade 4 chondral lesion of > 1 cm ² [61]

• Previous ligament surgery on the affected or contralateral knees

• Cases involving litigation or Worker's Compensation

• Confirmed connective tissue disorder (ie: Ehlers-Danlos, Marfans)

• X-ray showing that tibial physis is not fused

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary Sport Medicine Centre	Calgary	Alberta	Canada	T2N 1N4

Sponsors and Collaborators

• University of Calgary
• Workers' Compensation Board, Alberta

Investigators

• Principal Investigator: Nicholas G Mohtadi, MD MSc FRCSC, University of Calgary Sport Medicine Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

• Mohtadi N. Development and validation of the quality of life outcome measure (questionnaire) for chronic anterior cruciate ligament deficiency. Am J Sports Med. 1998 May-Jun;26(3):350-9.
• Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005960. doi: 10.1002/14651858.CD005960.pub2. Review.

• Responsible Party: Dr. Nicholas Mohtadi, Clinical Professor and Orthopaedic Surgeon, University of Calgary
• ClinicalTrials.gov Identifier: NCT00529958
• Other Study ID Numbers: REB15-1061 (formerly 20966)
• First Posted: Sep 14, 2007
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Dr. Nicholas Mohtadi, Clinical Professor and Orthopaedic Surgeon, University of Calgary: Anterior Cruciate Ligament (ACL) Reconstruction; Patellar Tendon; Hamstring Tendon; Double-Bundle; Autograft
• Additional relevant MeSH terms: Rupture; Anterior Cruciate Ligament Injuries

Study Results

Participant Flow

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Period Title: 2-Year Follow-up
STARTED	110	110	110
COMPLETED	106	108	108
NOT COMPLETED	4	2	2
Period Title: 2-Year Follow-up
STARTED	106	108	108
COMPLETED	103	105	107
NOT COMPLETED	3	3	1

Baseline Characteristics

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)	Total
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft	Total of all reporting groups
Overall Participants	110	110	110	330
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.7 (9.7)	28.5 (9.9)	28.3 (9.8)	28.5 (9.8)
Sex: Female, Male (Count of Participants)
Female	47 42.7%	51 46.4%	49 44.5%	147 44.5%
Male	63 57.3%	59 53.6%	61 55.5%	183 55.5%
Chronicity: Acute, Chronic (Count of Participants)
Acute	16 14.5%	16 14.5%	17 15.5%	49 14.8%
Chronic	94 85.5%	94 85.5%	93 84.5%	281 85.2%
Injured side: Left, Right (Count of Participants)
Left	54 49.1%	63 57.3%	54 49.1%	171 51.8%
Right	56 50.9%	47 42.7%	56 50.9%	159 48.2%

Outcome Measures

1. Primary Outcome

Title	Anterior Cruciate Ligament Quality of Life (ACL-QOL) Outcome
Description	The 32-item patient-reported Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) questionnaire assesses symptoms/physical complaints, work-related, sports/recreational, lifestyle and social/emotional concerns. A higher score on the 0 to 100mm visual analog scale represents better quality of life.
Time Frame	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	27.0 (13.1)	29.8 (14.7)	28.7 (13.7)
3 Months	47.7 (17.2)	52.6 (19.2)	50.5 (16.9)
6 Months	61.7 (19.1)	65.2 (18.4)	65.5 (17.9)
1-Year	74.5 (18.7)	75.4 (18.5)	73.6 (19.2)
2-Years	84.6 (16.6)	82.5 (17.7)	82.4 (17.5)
5-Years	82.5 (17.9)	83.9 (18.2)	81.1 (19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Patellar Tendon (PT), Hamstring (HT), Double-Bundle (DB)
	Comments	All patients were analyzed on an "intention-to-treat" basis using a 5% significance level for all analyses. The ACL-QOL scores for each study group were analyzed using adjusted Bonferroni comparisons and repeated-measures analyses, using a mixed-model analysis of variance for treatment group over time of assessment.
	Type of Statistical Test	Equivalence
	Comments	The sample size calculation was based on 88 ACL-deficient patients with surgical intervention and an ACL-QOL score of 74.5 (SD=20.1) at a mean 39-month follow-up, a minimal clinically important difference of 10 points, power=0.80 and p=0.05.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	A Bonferroni adjustment for multiple comparisons was used in the sample size calculation, resulting in 90 patients per group. With a 20% lost-to-follow-up rate, the final sample size was 108 patients per group for a total of 324 patients.
	Method	Mixed Models Analysis
	Comments

2. Secondary Outcome

Title	Number of Participants With Traumatic ACL Re-ruptures and Atraumatic Graft Failures
Description	COMPLETE TRAUMATIC RE-RUPTURE - defined as a consequence of an acute traumatic event resulting in a change in static stability since the most recent follow-up visit; determined clinically by a definite loss of end point on Lachman testing, increased anterior translation (>3mm) and a greater than or equal grade 2 pivot shift. Confirmed by MRI or diagnostic arthroscopy. PARTIAL TRAUMATIC TEARS - defined as a consequence of an acute traumatic event resulting in a suspected meniscal injury or graft tear on history, without the clinical characteristics of a "complete traumatic rerupture". Confirmed by MR or diagnostic arthroscopy. TRAUMATIC RE-INJURY - combined total of "complete traumatic re-ruptures" and "partial traumatic tears". ATRAUMATIC GRAFT FAILURES - defined in the absence of an acute traumatic event, with greater than or equal grade 2 pivot shift and/or greater than or equal to 6mm side-to-side difference on the KT arthrometer.
Time Frame	Minimum 2-year Follow-up, and 5-Year Follow-up

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
No re-injury or failure	91 82.7%	81 73.6%	79 71.8%
Complete Traumatic Re-rupture	3 2.7%	7 6.4%	7 6.4%
Partial Traumatic Tear	0 0%	5 4.5%	4 3.6%
Atraumatic Graft Failure	16 14.5%	17 15.5%	20 18.2%
No re-injury or failure	92 83.6%	80 72.7%	76 69.1%
Complete Traumatic Re-rupture	4 3.6%	11 10%	11 10%
Partial Traumatic Tear	0 0%	5 4.5%	6 5.5%
Atraumatic Graft Failure	7 6.4%	9 8.2%	14 12.7%

3. Secondary Outcome

Title	Number of Participants With Each International Knee Documentation Committee (IKDC) Objective Overall Group Grade
Description	IKDC Objective group grades: Normal (A), Nearly Normal (B), Abnormal (C), Severely Abnormal (D) The IKDC Objective Overall Group Grade is determined by the lowest grade assigned to defined objective knee examination measurements, including effusion, passive motion deficit and manual/instrumented ligament examinations (i.e. Lachman, anterior-posterior (AP) translation).
Time Frame	Baseline, 1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1-, 2-, and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Normal (A)	0 0%	0 0%	0 0%
Nearly Normal (B)	1 0.9%	4 3.6%	5 4.5%
Abnormal (C)	103 93.6%	101 91.8%	100 90.9%
Severely Abnormal (D)	5 4.5%	4 3.6%	5 4.5%
Normal (A)	9 8.2%	9 8.2%	9 8.2%
Nearly Normal (B)	79 71.8%	77 70%	71 64.5%
Abnormal (C)	13 11.8%	18 16.4%	19 17.3%
Severely Abnormal (D)	0 0%	0 0%	2 1.8%
Normal (A)	12 10.9%	12 10.9%	19 17.3%
Nearly Normal (B)	65 59.1%	62 56.4%	56 50.9%
Abnormal (C)	23 20.9%	28 25.5%	30 27.3%
Severely Abnormal (D)	1 0.9%	2 1.8%	2 1.8%
Normal (A)	24 21.8%	18 16.4%	19 17.3%
Nearly Normal (B)	61 55.5%	63 57.3%	58 52.7%
Abnormal (C)	13 11.8%	18 16.4%	24 21.8%
Severely Abnormal (D)	0 0%	0 0%	2 1.8%

4. Secondary Outcome

Title	Mean International Knee Documentation Committee (IKDC) Subjective Score
Description	Patient-reported health-related outcome measure with a score between 0 and 100. A higher score represents a better outcome.
Time Frame	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	50.1 (13.9)	51.0 (16.2)	51.5 (14.6)
3 Months	60.2 (12.2)	65.7 (14.2)	63.1 (12.1)
6 Months	71.1 (11.1)	76.1 (13.1)	75.8 (11.1)
1-Year	79.7 (11.7)	81.7 (12.6)	80.0 (11.9)
2-Years	84.6 (13.8)	85.3 (11.6)	84.2 (11.8)
5-Years	83.9 (12.9)	85.2 (13.0)	84.3 (13.4)

5. Secondary Outcome

Title	Number of Participants With Each Pivot Shift Grade
Description	The Pivot Shift test is a dynamic, passive test to assess the rotational instability of the Anterior Cruciate Ligament in the knee. Pivot shift grades include: equal/0 (negative); glide/1; clunk/2; gross/3. A positive grade indicates injury to the Anterior Cruciate Ligament.
Time Frame	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Equal	0 0%	1 0.9%	0 0%
Glide (+)	6 5.5%	6 5.5%	9 8.2%
Clunk (++)	103 93.6%	102 92.7%	99 90%
Gross (+++)	1 0.9%	1 0.9%	2 1.8%
Equal	73 66.4%	60 54.5%	80 72.7%
Glide (+)	30 27.3%	45 40.9%	25 22.7%
Clunk (++)	1 0.9%	1 0.9%	2 1.8%
Gross (+++)	0 0%	0 0%	0 0%
Equal	62 56.4%	53 48.2%	66 60%
Glide (+)	38 34.5%	45 40.9%	39 35.5%
Clunk (++)	3 2.7%	5 4.5%	2 1.8%
Gross (+++)	0 0%	0 0%	0 0%
Equal	47 42.7%	46 41.8%	53 48.2%
Glide (+)	51 46.4%	48 43.6%	41 37.3%
Clunk (++)	3 2.7%	12 10.9%	7 6.4%
Gross (+++)	0 0%	0 0%	1 0.9%
Equal	36 32.7%	28 25.5%	38 34.5%
Glide (+)	52 47.3%	57 51.8%	49 44.5%
Clunk (++)	14 12.7%	18 16.4%	19 17.3%
Gross (+++)	0 0%	1 0.9%	1 0.9%
Equal	37 33.6%	29 26.4%	30 27.3%
Glide (+)	50 45.5%	54 49.1%	50 45.5%
Clunk (++)	12 10.9%	16 14.5%	22 20%
Gross (+++)	0 0%	0 0%	1 0.9%

6. Secondary Outcome

Title	Proportion of Patients With Moderate or Severe Kneeling Pain
Description	Patients kneeled down on the same hard surface (i.e. clinic floor) and self-reported the pain on a scale of: none, mild, moderate or severe. The number of patients reporting moderate or severe kneeling pain were combined in the reported proportions.
Time Frame	Baseline, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

At 2 and 5-year follow-up, outcome data was not collected on all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	29 26.4%	29 26.4%	18 16.4%
2 Years	17 15.5%	9 8.2%	4 3.6%
5 Years	10 9.1%	4 3.6%	2 1.8%

7. Secondary Outcome

Title	Knee Laxity as Measured by the KT Arthrometer
Description	Mean side-to-side differences, as measured using the KT-1000 Arthrometer instrument at 30lbs/134N forces to objectively measure knee laxity.
Time Frame	Baseline, 1 and 2 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	4.9 (2.3)	5.0 (2.1)	5.1 (2.3)
1-Year	1.9 (2.3)	2.8 (1.8)	2.8 (2.2)
2-Years	1.9 (2.5)	3.0 (2.1)	2.7 (2.4)

8. Secondary Outcome

Title	Mean Tegner Activity Level
Description	Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10))
Time Frame	Baseline, 6 months, 1 and 2 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	7.7 (1.7)	7.9 (1.7)	7.9 (1.6)
6 Months	4.7 (1.6)	4.8 (1.6)	5.0 (1.7)
1 Year	6.0 (1.8)	6.1 (1.9)	5.9 (2.0)
2 Years	6.5 (1.8)	6.4 (2.0)	6.4 (1.9)

9. Secondary Outcome

Title	Return to Pre-injury Tegner Activity Level
Description	Proportion of patients returning to pre-injury levels, as measured by the Tegner Activity Scale (Values indicate level of activity from inactive (Level 0) to competitive level of activity (Level 10)).
Time Frame	1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1-, 2- and 5-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
1 Year	27 24.5%	33 30%	28 25.5%
2 Years	44 40%	43 39.1%	36 32.7%
5 Years	35 31.8%	41 37.3%	41 37.3%

10. Secondary Outcome

Title	Cincinnati Occupational Rating Scale
Description	The Cincinnati Occupational Rating Scale assesses the level of work-related activities, including sitting, standing, walking, squatting, climbing, lifting and carrying weighted objects. The score ranges from 0 to 100, with a lower score representing more sedentary work-related activities.
Time Frame	Baseline, 3 and 6 months, 1, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

There were 110 participants randomized to each study group. At 1- and 2-year follow-up, outcome data was not collected for all participants due to loss-to-follow-up, withdrawal or missed study visits.

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Baseline	36.6 (19.9)	35.4 (21.3)	36.3 (17.7)
3 Months	34.7 (17.2)	36.1 (22.1)	36.4 (19.3)
6 Months	35.7 (18.3)	37.4 (21.6)	37.0 (20.2)
1 Year	36.7 (17.2)	38.0 (22.0)	38.0 (21.5)
2 Years	36.8 (19.4)	34.4 (22.1)	38.0 (22.5)
5 Years	35.9 (18.4)	36.6 (23.8)	37.8 (24.2)

11. Secondary Outcome

Title	Skin-to-Skin Operative Times
Description	Skin-to-skin operative times (in minutes) for each ACL reconstruction procedure
Time Frame	During surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Mean (Standard Deviation) [Minutes]	75.3 (14.7)	67.8 (14.6)	88.0 (14.9)

12. Secondary Outcome

Title	Radiographic (X-ray) Changes
Description	The analysis for the radiographic assessment data is currently ongoing, to provide a comparison of baseline, 2- and 5-year post-operative x-rays.
Time Frame	Baseline, 2 and 5 years post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Other Pre-specified Outcome

Title	Complications of the Surgical Procedure (See Adverse Events Section for Results of This Outcome)
Description	All complications/adverse events that occurred within the first two-years post-operatively. See Adverse Events section for results of this outcome.
Time Frame	2 years post-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patellar Tendon (PT)	Hamstring (HT)	Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft	ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft	ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
Measure Participants	110	110	110
Deep wound infection	1 0.9%	0 0%	0 0%
Superficial wound infection	0 0%	2 1.8%	2 1.8%
Chondral lesion	1 0.9%	0 0%	1 0.9%
Failed meniscal repair	2 1.8%	6 5.5%	4 3.6%
Stiffness	4 3.6%	2 1.8%	3 2.7%
Hamstring injury	1 0.9%	6 5.5%	12 10.9%
Tibial periostitis	1 0.9%	2 1.8%	4 3.6%
Stitch abscess	2 1.8%	1 0.9%	0 0%
Cellulitis	0 0%	0 0%	3 2.7%
Meniscal cyst	1 0.9%	0 0%	0 0%
Patellar tendinopathy	1 0.9%	0 0%	0 0%
Persistent effusion / inflammation	1 0.9%	2 1.8%	5 4.5%
Sensory nerve problems	4 3.6%	1 0.9%	3 2.7%
Wound dehiscence	1 0.9%	0 0%	1 0.9%
Hardware issues	0 0%	0 0%	0 0%
Massive pulmonary embolism	0 0%	0 0%	1 0.9%
Deep vein thrombosis	0 0%	0 0%	1 0.9%
Septic arthritis	0 0%	1 0.9%	0 0%

Adverse Events

Time Frame	Two years post-operatively.
Adverse Event Reporting Description	Patient-reported adverse events by phone, email or at regularly scheduled follow-up visits. Unexpected/unusual problems with the patient's knee were assessed in clinic, diagnosed and managed accordingly. Patients presenting with emergent concerns were initially seen in the hospital emergency department. All patients experiencing an adverse event/complication were followed (by phone, email, regularly scheduled or additional visits) until the issue was completely resolved or appropriately managed.
Arm/Group Title	Patellar Tendon (PT)		Hamstring (HT)		Double-Bundle (DB)
Arm/Group Description	ACL reconstruction using a patellar tendon autograft Patellar Tendon: Patellar Tendon autograft		ACL reconstruction using a quadruple-strand semitendinosus/gracilis (hamstring) tendon single-bundle autograft Hamstring Tendon: Quadruple Semitendinosus/Gracilis (Hamstring) Tendon Autograft		ACL reconstruction using a semitendinosus/gracilis (hamstring) tendon double-bundle autograft Double-Bundle: Double-Bundle Semitendinosus/Gracilis (Hamstring) Tendon Autograft
All Cause Mortality
	Patellar Tendon (PT)		Hamstring (HT)		Double-Bundle (DB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		0/110 (0%)		0/110 (0%)
Serious Adverse Events
	Patellar Tendon (PT)		Hamstring (HT)		Double-Bundle (DB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/110 (0%)		1/110 (0.9%)		2/110 (1.8%)
Blood and lymphatic system disorders
Massive Pulmonary Embolism	0/110 (0%)		0/110 (0%)		1/110 (0.9%)
Deep Vein Thrombosis	0/110 (0%)		0/110 (0%)		1/110 (0.9%)
Infections and infestations
Septic Arthritis	0/110 (0%)		1/110 (0.9%)		0/110 (0%)
Other (Not Including Serious) Adverse Events
	Patellar Tendon (PT)		Hamstring (HT)		Double-Bundle (DB)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/110 (18.2%)		22/110 (20%)		38/110 (34.5%)
Infections and infestations
Deep Wound Infection	1/110 (0.9%)		0/110 (0%)		0/110 (0%)
Superficial Wound Infection	0/110 (0%)		2/110 (1.8%)		2/110 (1.8%)
Metabolism and nutrition disorders
Chondral Lesion	1/110 (0.9%)		0/110 (0%)		1/110 (0.9%)
Musculoskeletal and connective tissue disorders
Failed Meniscal Repair	2/110 (1.8%)		6/110 (5.5%)		4/110 (3.6%)
Stiffness	4/110 (3.6%)		2/110 (1.8%)		3/110 (2.7%)
Hamstring Injury	1/110 (0.9%)		6/110 (5.5%)		12/110 (10.9%)
Tibial Periostitis	1/110 (0.9%)		2/110 (1.8%)		4/110 (3.6%)
Stitch Abscess	2/110 (1.8%)		1/110 (0.9%)		0/110 (0%)
Cellulitis	0/110 (0%)		0/110 (0%)		3/110 (2.7%)
Meniscal Cyst	1/110 (0.9%)		0/110 (0%)		0/110 (0%)
Patellar Tendinopathy	1/110 (0.9%)		0/110 (0%)		0/110 (0%)
Persistent Effusion/Inflammation	1/110 (0.9%)		2/110 (1.8%)		5/110 (4.5%)
Nervous system disorders
Sensory Nerve Problems	4/110 (3.6%)		1/110 (0.9%)		3/110 (2.7%)
Skin and subcutaneous tissue disorders
Wound Dehiscence	1/110 (0.9%)		0/110 (0%)		1/110 (0.9%)
Surgical and medical procedures
Hardware Issues	0/110 (0%)		0/110 (0%)		0/110 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.