NCT00971074

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

September 2, 2009

Last Update Submit

February 24, 2021

Conditions

Arthralgia

Keywords

ArthralgiaViscosupplementationKneeMenisci, TibialSurgery, Outpatient

Outcome Measures

Primary Outcomes (1)

  • VAS pain scale

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

Hylan G-F 20

EXPERIMENTAL

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

Drug: Hylan G-F 20

Sham Injection

SHAM COMPARATOR

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

Other: Sham Injection

Interventions

Hylan G-F 20DRUG

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

Also known as: Synvisc One
Hylan G-F 20
Sham InjectionOTHER

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

Sham Injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Sports Medicine Center

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Arthralgia

Interventions

hylansalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Grant Jones, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor-Clinical, Orthopaedics

Study Record Dates

First Submitted

September 2, 2009

First Posted

September 3, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

US(1)