Status:
WITHDRAWN
Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy
Lead Sponsor:
Grant Jones
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Arthralgia
Eligibility:
All Genders
18-60 years
Phase:
NA
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 compar...
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- ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00971074
Start Date
December 1 2009
End Date
December 1 2011
Last Update
February 25 2021
Active Locations (1)
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1
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221