Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Sponsor

Grant Jones (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00971074

Collaborator

Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. The investigators would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.

Condition or Disease	Intervention/Treatment	Phase
Arthralgia	Drug: Hylan G-F 20 Other: Sham Injection	N/A

Detailed Description

A great majority of patients who have a partial menisectomy for mechanical symptoms do well with full return of function without pain. There is a sub-group of patients who are found to have Grade II- III chondromalacia lesions (deemed arthritic) at the time of surgery that have persistent generalized "arthritic-type" pain despite relief of their mechanical symptoms. To date, there are no published studies analyzing if this treatment is better than no treatment in this group of patients. We would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hylan G-F 20 Single injection of Hylan G-F 20 into the affected knee.	Drug: Hylan G-F 20 6 ml intra-articular injection given once. The injection takes approximately 15 seconds. Other Names: Synvisc One
Sham Comparator: Sham Injection A needle will be inserted through the knee capsule but no medication will be injected.	Other: Sham Injection A needle will be inserted through the knee capsule but no medication will be injected.

Arm

Intervention/Treatment

Experimental: Hylan G-F 20

Single injection of Hylan G-F 20 into the affected knee.

Drug: Hylan G-F 20

6 ml intra-articular injection given once. The injection takes approximately 15 seconds.

Other Names:

Synvisc One

Sham Comparator: Sham Injection

A needle will be inserted through the knee capsule but no medication will be injected.

Other: Sham Injection

A needle will be inserted through the knee capsule but no medication will be injected.

Outcome Measures

Primary Outcome Measures

VAS pain scale [0, 2, 6, 12, 18, 26 weeks]

Secondary Outcome Measures

Knee injury and Osteoarthritis Outcome Score [0, 2, 6, 12, 18, 26 weeks]
SF-36® Health Survey [0, 2, 6, 12, 18, 26 weeks]
Physical Examination [0, 2, 6, 12, 18, 26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-60
S/P partial medial and/or lateral partial meniscectomy
Pre-operative MRI diagnosed meniscal tear
Diffuse, non-focal arthroscopically diagnosed ICRS Grade II or III chondromalacia. (used to determine the presence of tibiofemoral osteoarthritis)
Baseline VAS pain score between 50 and 80mm.
Persistent, generalized knee pain without mechanical symptoms
Kellgren/Lawrence (K/L) grade II or III (used to determine the presence of tibiofemoral osteoarthritis)

Exclusion Criteria:

Bilateral arthroscopy (within 6 months pre- and post- initial VAS score.
Complete meniscectomy
Microfracture (via drilling, picking, abrading, thermal or radiofrequency or any procedure that violates the subchondral plate)
Focal chondral lesion visualized on arthroscopy or any focal cartilage procedure (e.g. ACI, OATS, mosaicplasty, etc)
Concomitant ligamentous injury or repair
K/L stage I or IV
Significant Varus or Valgus clinical malalignment
S/P tibial osteotomy in target knee
Isolated patello-femoral OA or isolated anterior knee pain
Prosthetic implant in either knee
Re-injury in time between original surgery and baseline visit
Inflammatory arthritis (e.g. rheumatoid arthritis, gout, pseudogout (chondrocalcinosis), lupus, etc)
Obesity with BMI > 35 (at time of initial VAS score
NSAIDs or opiates within one week of baseline randomization or during trial period
Known allergy to viscosupplements, known allergy to avian, egg or feather products
Prior Viscosupplementation use in ipsilateral knee
Oral steroids (within 4 weeks of initial VAS score)
IA steroids in target knee within 6 months
Significant medical co-morbidities ( e.g. malignancy, hepatic, renal, cardiac, pulmonary, gastrointestinal disease) in the judgment of the investigator
Known hip disease
Pregnant or nursing (at time of injection, pregnancy test at visit)
Active infection of either lower extremity or past history of septic arthritis
Venous or lymphatic stasis in either lower extremity
Enrolled in clinical trial within 3 months of baseline
Contralateral knee arthritis