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

Primary Purpose

Hip Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Hyaluronan

Bupivacaine

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hyaluronan

Bupivacaine

Arm Description

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

one Marcain extra-capsular injection

Outcomes

Primary Outcome Measures

Change in hip flexion-extension range of motion

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

Change in daily physical activity

Intensity and duration of the daily physical activity measured with pedometer

Secondary Outcome Measures

Change in hip pain

Questionnaires HOOS

Change in quality of life

Questionnaires: MOS-SF36 and HOOS

Change in walking cadence

Measured during 3D gait analysis

Full Information

NCT ID

NCT02086474

First Posted

March 7, 2014

Last Updated

August 9, 2018

Sponsor

Laval University

1. Study Identification

Unique Protocol Identification Number

NCT02086474

Brief Title

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

Official Title

Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronan

Arm Type

Experimental

Arm Description

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

Arm Title

Bupivacaine

Arm Type

Placebo Comparator

Arm Description

one Marcain extra-capsular injection

Intervention Type

Drug

Intervention Name(s)

Hyaluronan

Other Intervention Name(s)

Hyaluronan acid : Neovisc®

Intervention Description

Intra-articular injection

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Bupivacaine: Marcaine®

Intervention Description

Extra-capsular injection

Primary Outcome Measure Information:

Title

Change in hip flexion-extension range of motion

Description

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

Time Frame

Change from Baseline at 6 months

Title

Change in daily physical activity

Description

Intensity and duration of the daily physical activity measured with pedometer

Time Frame

Change from Baseline at 6 months

Secondary Outcome Measure Information:

Title

Change in hip pain

Description

Questionnaires HOOS

Time Frame

change from Baseline at 6 months

Title

Change in quality of life

Description

Questionnaires: MOS-SF36 and HOOS

Time Frame

Change from Baseline at 6 months

Title

Change in walking cadence

Description

Measured during 3D gait analysis

Time Frame

Change from Baseline at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antoine Cantin-Warren, B.Sc.

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Étienne L. Belzile, MD

Organizational Affiliation

Laval University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Philippe Corbeil, Ph.D.

Organizational Affiliation

Laval University

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Quebec

ZIP/Postal Code

G1V 0A6

Country

Canada

12. IPD Sharing Statement

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

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