NCT01478386

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

Randomized Trail to Assess the Effectiveness of an Off-Loading Knee Brace When Combined With Viscosupplementation in the Treatment of Knee Osteoarthritis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: OAD Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Orthovisc	Subjects will receive a series of three Orthovisc injections into their affected knee
DEVICE	DonJoy HA lite knee brace	Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-11-23
• Last updated: 2013-07-23

Locations

1 site across 1 country: United States