Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

This study has been withdrawn prior to enrollment.
(Patients did not meet inclusion criteria.)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Grant Jones, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00971074
First received: September 2, 2009
Last updated: March 27, 2012
Last verified: March 2012
  Purpose

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 Intervention
Arthralgia
Drug: Hylan G-F 20
Other: Sham Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • VAS pain scale [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ] [ Designated as safety issue: No ]
  • SF-36® Health Survey [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ] [ Designated as safety issue: No ]
  • Physical Examination [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971074

Locations
United States, Ohio
The Ohio State University Sports Medicine Center
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
Grant Jones
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Grant Jones, MD Ohio State University
  More Information

No publications provided

Responsible Party: Grant Jones, Associate Professor-Clinical, Orthopaedics, The Ohio State University
ClinicalTrials.gov Identifier: NCT00971074     History of Changes
Other Study ID Numbers: 2009H0156
Study First Received: September 2, 2009
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Arthralgia
Viscosupplementation
Knee
Menisci, Tibial
Surgery, Outpatient

Additional relevant MeSH terms:
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014