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

NCT02086474 | Completed Phase 4 DMC

• 1 other identifier: INF-2014
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Change in hip flexion-extension range of motion

  Subtraction between maximum and minimum flexion measured with motion capture system during gait

  Change from Baseline at 6 months

• Change in daily physical activity

  Intensity and duration of the daily physical activity measured with pedometer

  Change from Baseline at 6 months

Secondary Outcomes (3)

• Change in hip pain

  change from Baseline at 6 months

• Change in quality of life

  Change from Baseline at 6 months

• Change in walking cadence

  Change from Baseline at 6 months

Study Arms (2)

Hyaluronan

EXPERIMENTAL

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

Drug: Hyaluronan

Bupivacaine

PLACEBO COMPARATOR

one Marcain extra-capsular injection

Drug: Bupivacaine

Interventions

Hyaluronan DRUG

Intra-articular injection

Also known as: Hyaluronan acid : Neovisc®

Hyaluronan

Bupivacaine DRUG

Extra-capsular injection

Also known as: Bupivacaine: Marcaine®

Bupivacaine

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Pavillon de l'Éducation Physique et des Sports - Université Laval

Québec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Hyaluronic Acid; Bupivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antoine Cantin-Warren, B.Sc.

  Laval University

  PRINCIPAL INVESTIGATOR

• Étienne L. Belzile, MD

  Laval University

  STUDY DIRECTOR

• Philippe Corbeil, Ph.D.

  Laval University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

CA (1)