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Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Primary Purpose

Arthralgia

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hylan G-F 20

Sham Injection

About this trial

This is an interventional treatment trial for Arthralgia focused on measuring Arthralgia, Viscosupplementation, Knee, Menisci, Tibial, Surgery, Outpatient

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

The Ohio State University Sports Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Hylan G-F 20

Sham Injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS pain scale

Secondary Outcome Measures

Knee injury and Osteoarthritis Outcome Score

SF-36® Health Survey

Physical Examination

Full Information

NCT ID

NCT00971074

First Posted

September 2, 2009

Last Updated

February 24, 2021

Sponsor

Grant Jones

Collaborators

Genzyme, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00971074

Brief Title

Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Patients did not meet inclusion criteria.

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Grant Jones

Collaborators

Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthralgia

Keywords

Arthralgia, Viscosupplementation, Knee, Menisci, Tibial, Surgery, Outpatient

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hylan G-F 20

Arm Type

Experimental

Arm Description

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

Arm Title

Sham Injection

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hylan G-F 20

Other Intervention Name(s)

Synvisc One

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

VAS pain scale

Time Frame

0, 2, 6, 12, 18, 26 weeks

Secondary Outcome Measure Information:

Title

Knee injury and Osteoarthritis Outcome Score

Time Frame

0, 2, 6, 12, 18, 26 weeks

Title

SF-36® Health Survey

Time Frame

0, 2, 6, 12, 18, 26 weeks

Title

Physical Examination

Time Frame

0, 2, 6, 12, 18, 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Grant Jones, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University Sports Medicine Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

12. IPD Sharing Statement

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Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

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