Hip OsteoarthritisPhase 4NCT02086474
Daily Activity and Gait Analysis After Viscosupplement Injection Among Hip Osteoarthritis Patients
A Phase 4 study testing Hyaluronan and Bupivacaine in people with Hip Osteoarthritis, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Hyaluronan and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Pavillon de l'Éducation Physique et des Sports - Université Laval
Québec, G1V 0A6
About this study
Official title: Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients
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
- Being tested
- Hyaluronan, Bupivacaine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyaluronanDrug
Also called Hyaluronan acid : Neovisc®
Intra-articular injection
BupivacaineDrug
Also called Bupivacaine: Marcaine®
Extra-capsular injection
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronan | Experimental | Hyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection Receives: Drug: Hyaluronan |
| Bupivacaine | Placebo comparator | one Marcain extra-capsular injection Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hip flexion-extension range of motion
Subtraction between maximum and minimum flexion measured with motion capture system during gait
Measured: Change from Baseline at 6 months
Change in daily physical activity
Intensity and duration of the daily physical activity measured with pedometer
Measured: Change from Baseline at 6 months
Secondary outcomes (3)
Change in hip pain
Questionnaires HOOS
Measured: change from Baseline at 6 months
Change in quality of life
Questionnaires: MOS-SF36 and HOOS
Measured: Change from Baseline at 6 months
Change in walking cadence
Measured during 3D gait analysis
Measured: Change from Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe Corbeil, Laval University
- Investigators
- Antoine Cantin-Warren, B.Sc., Principal investigator, Laval UniversityÉtienne L. Belzile, MD, Study director, Laval UniversityPhilippe Corbeil, Ph.D., Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086474
- Sponsor's protocol ID
- INF-2014
- Status last verified
- Aug 2018
- First submitted
- 7 Mar 2014
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Activity Quantification and Gait Pattern Analysis Before and After Intra-articular Injection of Viscosupplement Among Hip Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT02086474
- Acronym / sponsor ID
- INF-2014
- Conditions
- Hip Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronan | Experimental | Drug: HyaluronanHyaluronan acid Neovisc : one 6cc (viscosupplement) intra-articular injection |
| Bupivacaine | Placebo comparator | Drug: Bupivacaineone Marcain extra-capsular injection |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyaluronanAlso: Hyaluronan acid : Neovisc®Intra-articular injection | Drug | Hyaluronan |
| BupivacaineAlso: Bupivacaine: Marcaine®Extra-capsular injection | Drug | Bupivacaine |
Primary outcome
Change in hip flexion-extension range of motion
Time frame: Change from Baseline at 6 months
Subtraction between maximum and minimum flexion measured with motion capture system during gait
Change in daily physical activity
Time frame: Change from Baseline at 6 months
Intensity and duration of the daily physical activity measured with pedometer
3 secondary outcomes
Change in hip pain
Time frame: change from Baseline at 6 months
Change in quality of life
Time frame: Change from Baseline at 6 months
Change in walking cadence
Time frame: Change from Baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Cantin-Warren, B.Sc. principal investigator
Laval University
Étienne L. Belzile, MD study director
Laval University
Philippe Corbeil, Ph.D. study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronan and Bupivacaine in people with Hip Osteoarthritis, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hip flexion-extension range of motion (time frame: Change from Baseline at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.