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

L

Laval University

Status and phase

Completed
Phase 4

Conditions

Hip Osteoarthritis

Treatments

Drug: Bupivacaine
Drug: Hyaluronan

Study type

Interventional

Funder types

Other

Identifiers

NCT02086474
INF-2014

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

38 participants in 2 patient groups, including a placebo group

Hyaluronan
Experimental group
Description:
Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection
Treatment:
Drug: Hyaluronan
Bupivacaine
Placebo Comparator group
Description:
one Marcain extra-capsular injection
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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