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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Viscosupplementation injections

Control group will receive a series of three viscosupplementation injections into the affected knee

Group Type OTHER

Orthovisc

Intervention Type OTHER

Subjects will receive a series of three Orthovisc injections into their affected knee

Off-loading knee brace

Group Type EXPERIMENTAL

DonJoy HA lite knee brace

Intervention Type DEVICE

Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee

Viscosupplementation and knee brace

Group Type EXPERIMENTAL

Orthovisc injections and DonJoy HA lite knee brace

Intervention Type DEVICE

Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace

Interventions

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Orthovisc

Subjects will receive a series of three Orthovisc injections into their affected knee

Intervention Type OTHER

DonJoy HA lite knee brace

Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee

Intervention Type DEVICE

Orthovisc injections and DonJoy HA lite knee brace

Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects, over the age of 18, with a diagnosis of knee osteoarthritis which is confirmed by radiographs.
* Radiographs will be obtained and patients with mild to moderate knee osteoarthritis will qualify a subject for enrollment.
* Subjects will also have a documented varus deformity.

Exclusion Criteria

* Subjects with severe arthritis as demonstrated by radiographs.
* In addition those subjects with a known or suspected joint infection and subjects who had undergone arthrocentesis and/or intra-articular injection within 3 months of the study will be excluded.
* Female patients who are pregnant or breast feeding will also be excluded.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes