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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01478386
• Other study ID #: Knee OA Treatments
• Status: Terminated
• Phase: N/A
• First received: November 21, 2011
• Last updated: July 22, 2013
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: OAD Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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
• 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

Locations

Country	Name	City	State
United States	OAD Orthopaedics	Warrenville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
OAD Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in knee pain	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.	3 months	No

External Links

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