Oxford Signature vs. Conventional Global Study

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01763684
• Collaborator: (none)
• Enrollment: 266
• Locations: 7
• Arms: 2
• Actual Duration (Months): 47
• Patients Per Site: 38
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis	Device: Signature Custom Guides; Procedure: Conventional Instrumentation	N/A

Detailed Description

The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:

1. Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation.

2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix.

3. Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 266 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Global Comparison of Signature Guides and Conventional Instrumentation in the Oxford Partial Knee
• Actual Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Signature Custom Guides Oxford Partial Knee implanted using Signature Custom Guides	Device: Signature Custom Guides; Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
Active Comparator: Conventional Instrumentation Oxford Partial Knee implanted using Conventional Instrumentation	Procedure: Conventional Instrumentation; Traditional partial knee arthroplasty without the use of Signature technology.

Outcome Measures

Primary Outcome Measures

1. Percentage of Knees Achieving Optimal Alignment [12 weeks]

   Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.

Secondary Outcome Measures

1. Instruments Used During Surgery [Operative]

   Number of Instrument cases used to complete index surgery.

2. Knee Society Functional Score [1 Year]

   Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions

3. Leg Alignment Femoral Varus/Valgus [Directly Postoperative]

   Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle

4. Blood Loss [Right after surgery (up to 2 hours after surgery)]

   Blood Loss during surgery

5. Knee Society Objective Score [1 Year]

   Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions

6. Oxford Knee Score [1 Year]

   Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome

7. EQ5D Score [1 Year]

   EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.

8. Leg Alignment Femoral Flexion/Extension [Directly Postoperative]

   Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle

9. Leg Alignment Tibial Varus/Valgus [Directly Postoperative]

   Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle

10. Leg Alignment Tibial Flexion/Extension [Directly Postoperative]

    Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease.

• Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases

• Patients 21 and over

Exclusion Criteria:

• Use of Cementless Fixation in the United States

• Infection, sepsis or osteomyelitis

• Use in lateral compartment of the knee

• Rheumatoid arthritis or other forms of inflammatory joint disease

• Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture

• Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device.

• Disease or damage to the lateral compartment of the knee

• Uncooperative patient or patient with neurologic disorders who is incapable of following directions

• Osteoporosis in the United States / Insufficient bone stock outside the United States

• Metabolic disorders which may impair bone formation

• Osteomalacia

• Distant foci of infections which may spread to implant site

• Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram

• Vascular insufficiency, muscular atrophy, neuromuscular disease.

• Incomplete or deficient soft tissue surrounding the knee.

• Charcot's disease

• A fixed varus deformity (not passively correctable) of greater than 15 degrees

• A flexion deformity greater than 15 degrees.

• Non-staged Bilateral patients

• Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orthopedic and Sports Medicine Center	Elkhart	Indiana	United States	46514
2	The Orthopaedic Center	Rockville	Maryland	United States	20850
3	University of Missouri-Columbia Hospital and Clinics	Columbia	Missouri	United States	65212
4	Duke University Medical Center	Durham	North Carolina	United States	27703
5	Joint Implant Surgeons	Columbus	Ohio	United States	43054
6	Texas Institute for Hip & Knee Surgery	Austin	Texas	United States	78751
7	Advanced Orthopedics	Richmond	Virginia	United States	23294

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: Russell Schenck, Ph.D., Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT01763684
• Other Study ID Numbers: ORTHO.CR.GK7
• First Posted: Jan 9, 2013
• Last Update Posted: Apr 23, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Zimmer Biomet: Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis; Arthritis; Knee Arthritis; Knee Replacement
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Osteonecrosis

Study Results

Participant Flow

Pre-assignment Detail	Bi-lateral treatment was not recorded. Each treated knee is counted as 1 participant.

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Period Title: Overall Study
STARTED	133	133
Completed Surgery	126	127
COMPLETED	0	0
NOT COMPLETED	133	133

Baseline Characteristics

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation	Total
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.	Total of all reporting groups
Overall Participants	126	127	253
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	77 61.1%	77 60.6%	154 60.9%
>=65 years	45 35.7%	49 38.6%	94 37.2%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	63.2 (10.0)	62.5 (9.1)	62.9 (9.7)
Sex: Female, Male (Count of Participants)
Female	56 44.4%	68 53.5%	124 49%
Male	70 55.6%	54 42.5%	124 49%
Region of Enrollment (participants) [Number]
United States	95 75.4%	71 55.9%	166 65.6%
Europe	25 19.8%	47 37%	72 28.5%
Australia	6 4.8%	4 3.1%	10 4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Knees Achieving Optimal Alignment
Description	Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

Data from all patients as treated

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	100	94
Number [percentage of total]	45	29

2. Secondary Outcome

Title	Instruments Used During Surgery
Description	Number of Instrument cases used to complete index surgery.
Time Frame	Operative

Outcome Measure Data

Analysis Population Description

All patients as treated

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	122	126
Mean (Standard Deviation) [Instrument cases]	4.2 (0.76)	3.8 (0.97)

3. Secondary Outcome

Title	Knee Society Functional Score
Description	Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score score completed

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	58	60
Mean (Standard Deviation) [units on a scale]	88.1 (18.2)	91.8 (14.2)

4. Secondary Outcome

Title	Leg Alignment Femoral Varus/Valgus
Description	Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time Frame	Directly Postoperative

Outcome Measure Data

Analysis Population Description

All patients as treated with post-operative CT collected

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	100	94
Mean (Standard Deviation) [Degrees]	3.55 (2.7)	4.75 (3.53)

5. Secondary Outcome

Title	Blood Loss
Description	Blood Loss during surgery
Time Frame	Right after surgery (up to 2 hours after surgery)

Outcome Measure Data

Analysis Population Description

All patients as treated for which blood loss is recorded

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	49	79
Mean (Standard Deviation) [ml]	81.9 (84.5)	54.8 (73.0)

6. Secondary Outcome

Title	Knee Society Objective Score
Description	Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score completed

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	58	60
Mean (Standard Deviation) [units on a scale from 0 to 100]	93.3 (16.3)	95.0 (17.5)

7. Secondary Outcome

Title	Oxford Knee Score
Description	Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

All patients, as treated, reaching the 1 year follow up datapoint with Oxford Knee Score completed

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	58	57
Mean (Standard Deviation) [units on a scale]	42.6 (6.1)	44.0 (4.9)

8. Secondary Outcome

Title	EQ5D Score
Description	EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

All patients, as treated, reaching the 1 year follow up datapoint with EQ5D score completed

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	58	58
Mean (Standard Deviation) [units on a scale from 0 to 1]	0.88 (0.15)	0.9 (0.19)

9. Secondary Outcome

Title	Leg Alignment Femoral Flexion/Extension
Description	Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time Frame	Directly Postoperative

Outcome Measure Data

Analysis Population Description

All patients as treated with post-operative CT collected

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	89	88
Mean (Standard Deviation) [Degrees]	3.48 (2.7)	4.59 (3.34)

10. Secondary Outcome

Title	Leg Alignment Tibial Varus/Valgus
Description	Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time Frame	Directly Postoperative

Outcome Measure Data

Analysis Population Description

All patients as treated with post-operative CT collected

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	100	91
Mean (Standard Deviation) [Degrees]	4.04 (2.41)	4.10 (2.39)

11. Secondary Outcome

Title	Leg Alignment Tibial Flexion/Extension
Description	Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time Frame	Directly Postoperative

Outcome Measure Data

Analysis Population Description

All patients as treated with post-operative CT collected

Arm/Group Title	Signature Custom Guides	Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).	Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
Measure Participants	94	100
Mean (Standard Deviation) [Degrees]	2.47 (2.06)	2.96 (2.04)

Adverse Events

Arm/Group Title	Signature Custom Guides		Conventional Instrumentation
Arm/Group Description	Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).		Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology.
All Cause Mortality
	Signature Custom Guides		Conventional Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/133 (0%)		0/133 (0%)
Serious Adverse Events
	Signature Custom Guides		Conventional Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/133 (2.3%)		6/133 (4.5%)
Gastrointestinal disorders
PERFORATED DIVERTICULITIS, HINCHEY IV	0/133 (0%)	0	1/133 (0.8%)	1
LAPARAOSCIPIC GASTRIC BYPASS	1/133 (0.8%)	1	0/133 (0%)	0
General disorders
Patient Fall	0/133 (0%)	0	1/133 (0.8%)	1
Unkown event	0/133 (0%)	0	1/133 (0.8%)	1
Musculoskeletal and connective tissue disorders
DEHISCENCE OF PROXIMAL MEDIAL CAPSULAR SUTURE	1/133 (0.8%)	1	0/133 (0%)	0
ARTHROSCOPIC PROCEDURE	1/133 (0.8%)	1	0/133 (0%)	0
SHOULDER PAIN	0/133 (0%)	0	1/133 (0.8%)	1
Knee Pain	0/133 (0%)	0	1/133 (0.8%)	1
Knee Gonarthrosis	0/133 (0%)	0	1/133 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Signature Custom Guides		Conventional Instrumentation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/133 (9%)		18/133 (13.5%)
Gastrointestinal disorders
Constipation	0/133 (0%)	0	1/133 (0.8%)	1
General disorders
Fall	0/133 (0%)	0	1/133 (0.8%)	1
Injury, poisoning and procedural complications
2 MM BLOOD BLISTER ON INCISION ON OPERATIVE KNEE	0/133 (0%)	0	1/133 (0.8%)	1
DELAYED WOUND HEALING	0/133 (0%)	0	1/133 (0.8%)	1
POST-OP NAUSEA	2/133 (1.5%)	2	2/133 (1.5%)	2
Rib Fracture	0/133 (0%)	0	1/133 (0.8%)	1
Musculoskeletal and connective tissue disorders
DEGENERATIVE DISC DISEASE LUMBAR SPINE	0/133 (0%)	0	1/133 (0.8%)	1
Disease Progression	1/133 (0.8%)	1	0/133 (0%)	0
FEELING OF RIGHT KNEE GIVING WAY	0/133 (0%)	0	1/133 (0.8%)	1
Knee pain	7/133 (5.3%)	7	3/133 (2.3%)	3
Knee popping/clicking	0/133 (0%)	0	3/133 (2.3%)	3
Knee Swelling	1/133 (0.8%)	1	2/133 (1.5%)	2
PATELLA TENDONITIS	1/133 (0.8%)	1	0/133 (0%)	0
Skin and subcutaneous tissue disorders
Skin Irritation	0/133 (0%)	0	1/133 (0.8%)	1

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.