Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-08-31

Brief Summary

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The objective of this study is to assess the changes in daily physical activity and gait pattern, following a viscosupplement injection among a population who is suffering from hip osteoarthritis. A kinetic and kinematic gait analysis, an Actigraph activity monitor, a functional Timed-Stair-Test and two questionnaires (Medical Outcome Study Short-Form36 (MOS-SF36), Hip disability and Osteoarthritis Outcome Score (HOOS)) about how the pathology affects the quality of life, will be use.

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Detailed Description

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Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hyaluronan

Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection

Group Type EXPERIMENTAL

Hyaluronan

Intervention Type DRUG

Intra-articular injection

Bupivacaine

one Marcain extra-capsular injection

Group Type PLACEBO_COMPARATOR

Bupivacaine

Intervention Type DRUG

Extra-capsular injection

Interventions

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Hyaluronan

Intra-articular injection

Intervention Type DRUG

Bupivacaine

Extra-capsular injection

Intervention Type DRUG

Other Intervention Names

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Hyaluronan acid : Neovisc® Bupivacaine: Marcaine®

Eligibility Criteria

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Inclusion Criteria

* From 45 years old to 65 years old
* Clinically symptomatic moderate or severe hip osteoarthritis (Tönnis Grade II to III)
* Capacity to keep steady upright position and walking during 15 minutes
* Body mass index \< 40kg/m2

Exclusion Criteria

* Bilateral hip osteoarthritis
* No broken hip or leg during the last 12 months
* Bone necrosis
* Rheumatoid arthritis, articular chondrocalcinosis, metabolic bone disease, psoriasis, gout, active infection
* Per os corticosteroid treatment
* Corticosteroid injection \< 3 months
* Viscosupplement injection \< 6 months
* Hypersensitivity to hyaluronic acid products
* Planed surgery during study duration
* Physical or mental disability to fill in questionnaires and/or to participate to follow-up

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No