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

OAD Orthopaedics11 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

OrthoviscOTHER

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

DonJoy HA lite knee braceDEVICE

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 braceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

OAD Orthopaedics

Warrenville, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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