The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction

• Sponsor: Brian Walters (Other)
• Overall Status: Completed
• CT.gov ID: NCT01765712
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 56
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar tendons as autografts.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Biological: Platelet Rich Plasma	Phase 4

Detailed Description

There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation.

The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: "Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
• Actual Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Group Patients will be randomized into the treatment arm using a computer generated randomization table (simple randomization). Patients in the control arm of the study will undergo Anterior cruciate ligament reconstruction using Autologous bone patellar tendon bone autograft. At the end of the surgery, their graft donor site will have bone graft chips placed into the bony defect and the wound will be closed using sutures.	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Other Names: ACL BPTB
Experimental: Platelet Rich Plasma Patients randomized into the treatment arm of the study will undergo Anterior cruciate ligament reconstruction with Autologous bone patellar tendon bone autografts. At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist. This sample will be spun down into 3-5cc of Platelet Rich Plasma which will be added to the patients bone graft chips and placed into the donor site at the end of the case.	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Other Names: ACL BPTB ; Biological: Platelet Rich Plasma; Other Names: PRP

Outcome Measures

Primary Outcome Measures

1. Anterior Knee Pain [2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.]

   The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months. The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.

Secondary Outcome Measures

1. Radiographic Assessment of Tunnel Positioning [3 months]

   A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.

2. Quantification of Healing at the Bony and Tendinous Harvest Sites [6 months]

   Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist.

3. Post Operative Strength [3,6,12,18,24months]

   The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment.

4. Post Operative Range of Motion [2 weeks, 1,3,6,12,18,24months]

   The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Primary ACL Reconstruction

• Outerbridge </= 2

• Minimum follow up of two years

• No ligamentous secondary injury

• Willingness to participate in study

Exclusion Criteria:

• Any previous knee injury

• prior history of anterior knee pain

• Outerbridge classification 3 or greater

• Revision ACL

• Diabetic or smoker

• Workers compensation patient

• pregnant or nursing women

• Any patient with limited English Proficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NY Orthopedics	New York	New York	United States	10021

Sponsors and Collaborators

• Brian Walters

Investigators

• Principal Investigator: Stephen Nicholas, MD, Northwell Health

Study Documents (Full-Text)

• Informed Consent Form - Sep 5, 2012
• Study Protocol and Statistical Analysis Plan - May 14, 2014

More Information

Publications

None provided.

• Responsible Party: Brian Walters, MD, Northwell Health
• ClinicalTrials.gov Identifier: NCT01765712
• Other Study ID Numbers: 12-160A
• First Posted: Jan 10, 2013
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Brian Walters, MD, Northwell Health: PRP; BPTB; VAS; Anterior Knee Pain
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Period Title: Overall Study
STARTED	27	23
COMPLETED	27	23
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	PRP Treatment	Sham Treatment	Total
Arm/Group Description	27 patients received the PRP treatment	23 patients received the sham treatment	Total of all reporting groups
Overall Participants	27	23	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	27 100%	23 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31 (12)	29 (12)	30 (12)
Sex: Female, Male (Count of Participants)
Female	17 63%	11 47.8%	28 56%
Male	10 37%	12 52.2%	22 44%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	27 100%	23 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Anterior Knee Pain
Description	The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months. The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.
Time Frame	2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.

Outcome Measure Data

Analysis Population Description

Kneeling pain for treatment groups at 2 years post-op.

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Measure Participants	27	23
Mean (Standard Deviation) [units on a scale]	2.4 (2.7)	1.9 (1.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRP Treatment, Sham
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 95%; -1.99 to 1.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Radiographic Assessment of Tunnel Positioning
Description	A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Was not measured

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Measure Participants	0	0

3. Secondary Outcome

Title	Quantification of Healing at the Bony and Tendinous Harvest Sites
Description	Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

MRI indices of donor site healing - defect in millimeters (mm)

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Measure Participants	27	23
Mean (Standard Deviation) [mm]	11.6 (2.4)	12.0 (3.1)

4. Secondary Outcome

Title	Post Operative Strength
Description	The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment.
Time Frame	3,6,12,18,24months

Outcome Measure Data

Analysis Population Description

Strength was not assessed

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Measure Participants	0	0

5. Secondary Outcome

Title	Post Operative Range of Motion
Description	The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician.
Time Frame	2 weeks, 1,3,6,12,18,24months

Outcome Measure Data

Analysis Population Description

ROM was not measured

Arm/Group Title	PRP Treatment	Sham
Arm/Group Description	Patients treated with PRP	Patients not receiving PRP
Measure Participants	0	0

Adverse Events

Time Frame	2 years
Arm/Group Title	PRP Treatment		Sham
Arm/Group Description	Patients treated with PRP		Patients not receiving PRP
All Cause Mortality
	PRP Treatment		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/23 (0%)
Serious Adverse Events
	PRP Treatment		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	PRP Treatment		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.