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

OAD Orthopaedics

Status: Terminated

Conditions: Knee Osteoarthritis

Treatments: Other: Orthovisc; Device: Orthovisc injections and DonJoy HA lite knee brace; Device: DonJoy HA lite knee brace

Study type: Interventional

Funder types: Other

Identifiers

NCT01478386

Knee OA Treatments

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 3 patient groups

Viscosupplementation injections

Other group

Description:

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

Treatment:

Other: Orthovisc

Off-loading knee brace

Experimental group

Treatment:

Device: DonJoy HA lite knee brace

Viscosupplementation and knee brace

Experimental group

Treatment:

Device: Orthovisc injections and DonJoy HA lite knee brace