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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086474
• Other study ID #: INF-2014
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2018
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Hyaluronan
Intra-articular injection
• Bupivacaine
Extra-capsular injection

Locations

Country	Name	City	State
Canada	Pavillon de l'Éducation Physique et des Sports - Université Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in daily physical activity	Intensity and duration of the daily physical activity measured with pedometer	Change from Baseline at 6 months
Secondary	Change in hip pain	Questionnaires HOOS	change from Baseline at 6 months
Secondary	Change in quality of life	Questionnaires: MOS-SF36 and HOOS	Change from Baseline at 6 months
Secondary	Change in walking cadence	Measured during 3D gait analysis	Change from Baseline at 6 months