Effectiveness of a Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Other: Orthovisc; Device: DonJoy HA lite knee brace; Device: Orthovisc injections and DonJoy HA lite knee brace

• Registration Number: NCT01478386
• Lead Sponsor: OAD Orthopaedics

Brief Summary

Hypothesis: Viscosupplementation when combined with an off-loading knee brace is more effective in treating the symptoms of knee OA then treating with viscosupplementation alone

Detailed Description

A randomized prospective study to assess the effectiveness of treating knee osteoarthritis with either a series of three viscosupplementation injections, an off-loading knee brace, or a combination of viscosupplementation and an off-loading knee brace. The viscosupplementation and off-loading knee brace are being used in accordance with their FDA approval. Subjects will be randomized to 1 of 3 treatment groups. The control group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections. The second group will receive a series of weekly (3 consecutive weeks) intra-articular hyaluronic acid injections and an off loading knee brace. The third group will use the off loading knee brace alone. Subjects will complete the WOMAC Osteoarthritis Questionnaire (pain, stiffness, function) and VAS pain scale (measuring pain on movement) at baseline, day 7, day 14, 6 weeks and 3 months. Subjects in group 2 and 3 will be given a brace diary to record compliance.

Study Timeline

• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-22
• Study First Posted: 2011-11-23
• Study Start: 2011-12
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viscosupplementation injections	Orthovisc	Control group will receive a series of three viscosupplementation injections into the affected knee
Off-loading knee brace	DonJoy HA lite knee brace	-
Viscosupplementation and knee brace	Orthovisc injections and DonJoy HA lite knee brace	-

Primary Outcome Measures

Name	Time	Method
Reduction in knee pain	3 months	The primary outcome measure will be a reduction in knee pain as measured by the VAS pain score. The secondary outcome measure will be an increase in function as measured by the WOMAC Osteoarthritis Questionnaire.

Trial Locations

Locations (1)

OAD Orthopaedics; 🇺🇸 Warrenville, Illinois, United States