CoxarthrosisPhase 3NCT01079455
Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip
A Phase 3 study testing Corticosterone in people with Coxarthrosis, run by University Hospital Pellenberg at 1 site in Belgium.
Trial summary
Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Corticosterone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 489 participants
- Where
- 1 siteBelgium
- Study dates
- May 2010to Dec 2013
- Phase
- Phase 3
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- an age between 30 and 70years
- radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
- chronic pain for at least 3 months prior to study entry (day 0)
- dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs.
Who cannot join
- Kellgren and Lawrence grade 4
- an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months
- non compliance to the study procedures and or non completion of the study according to investigator's judgment
- rapid destructive hip.
- a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy
- a current other problem in the affected extremity
- contra-indications for the use of corticosteroids (gastrointestinal ulcer, severe osteoporosis, psychiatric anamnesis, herpes simplex or zoster (viremic stadium), varicella, 8 weeks before and 2 weeks after immunization, systemic mycosis, poliomyelitic except of bulbar encephalitic form lymphadenitis after BCG-vaccination, parenteral depot medication, closed- and wide-angle glaucoma)
- allergy or hypersensitivity to any of the study medications or to contrast solutions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip Controlled With Intra-articular Injections With Bupivacaine
Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee.
Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%.
Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.
- Conditions
- Coxarthrosis
- Being tested
- Corticosterone
- Keywords
- Coxarthrosis, Hip, Infiltration, Hyaluronic Acid, Corticosterone
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroneDrug
Also called Hyaluronic Acid, Bupivacaine
Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
| Study group | Role | What they receive |
|---|---|---|
| HA | Active comparator | Coxarthrosis Receives: Drug: Corticosterone |
| Corticosterone | Active comparator | Coxarthrosis Receives: Drug: Corticosterone |
| Bupivacaine | Placebo comparator | Coxarthrosis Receives: Drug: Corticosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
this score will be used as a self-administered questionnaire in accordance with the developers' instructions. The Harris Hip Score was first developed in 1967 and is accepted as one of the best used questionnaires dealing the hip function. It is a disease-specific scoring system which was introduced to provide an evaluation system for various hip disabilities and methods of treatment. This Score gives a maximum of 100 points, with domains of pain, function, deformity and motion.
Measured: 0 - 6 - 12 - 26 weeks
Secondary outcomes (1)
Visual Analog Score
this score is a self-assessment of variation in pain intensity, measured on a simple 100-mm-long continuous scale of absolutes ranging from "no pain" to "extreme pain". The percentage of pain is determined by physical measuring from the end of the line to the patients' mark on the pain scale, and divided by total length of the line. The advantage of the VAS is that you can determine the change in pain by taking the difference between any two recordings of pain severity
Measured: 0 - 6 - 12 - 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoxarthrosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 489 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Pellenberg
- Sponsor type
- University, hospital or other
- Investigators
- Sascha Colen, MD, Principal investigator, University Hospital Pellenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079455
- Sponsor's protocol ID
- 2009-014274-17
- Other IDs
- 2009
- Status last verified
- Feb 2010
- First submitted
- 1 Mar 2010
- Last updated
- 3 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Colen S, van den Bekerom MP, Bellemans J, Mulier M. Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors. BMC Musculoskelet Disord. 2010 Nov 16;11:264. doi: 10.1186/1471-2474-11-264.
PubMed 21080920
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyaluronic Acid and Corticosteroid Intra-articular Injections for the Treatment of Osteoarthritis of the Hip Controlled With Intra-articular Injections With Bupivacaine
- ClinicalTrials.gov ID
- NCT01079455
- Acronym / sponsor ID
- 2009-014274-17
- Conditions
- Coxarthrosis
- Keywords
- Coxarthrosis, Hip, Infiltration, Hyaluronic Acid, Corticosterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 489 participants (estimated)
- Lead sponsor
- University Hospital PellenbergUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 3 Mar 2010 (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.
Abstract Background: The effect of intra-articular treatment of hip osteoarthritis with hyaluronic acid in the hip joint is not based on large randomized controlled trials. Hyaluronic acid is a well established treatment for osteoarthritis of the knee.
Methods: Randomized controlled trial with three-armed parallel-group design. The patients meeting the inclusion criteria will be randomized into one of the following groups: infiltration of the hip joint with hyaluronic acid, with corticosteroids or with bupivacaine 0,125%.
Pain VAS, Harris Hip Score and HOOS were scored during follow-up. The patients will be asked to determine their situation as worse, stabile or better then at the time of enrollment. There will be asked if they use painkillers and if they have complications/adverse events. These outcome measure instruments will be used at the time of enrollment in the study prior to any injection, and then again at six weeks, 3 and 6 months after the initial injection. The six-month follow-up period begins for all patients on the date the first injection will be administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HA | Active comparator | Drug: CorticosteroneCoxarthrosis |
| Corticosterone | Active comparator | Drug: CorticosteroneCoxarthrosis |
| Bupivacaine | Placebo comparator | Drug: CorticosteroneCoxarthrosis |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- an age between 30 and 70years
- radiographic evidence of OA of the hip (Kellgren-Lawrence grading scale 1-3)
- chronic pain for at least 3 months prior to study entry (day 0)
- dissatisfaction with prior attempts at non-operative management including nonsteroidal anti-inflammatory drugs.
Key exclusion criteria (8 listed)
- Kellgren and Lawrence grade 4
- an intra-articular hip injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months
- non compliance to the study procedures and or non completion of the study according to investigator's judgment
- rapid destructive hip.
- a history of crystalline arthropathy or inflammatory arthritis, neuropathic arthropathy
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 |
|---|---|---|
| CorticosteroneAlso: Hyaluronic Acid, BupivacaineHyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml | Drug | Bupivacaine, Corticosterone, HA |
Primary outcome
Harris Hip Score
Time frame: 0 - 6 - 12 - 26 weeks
this score will be used as a self-administered questionnaire in accordance with the developers' instructions. The Harris Hip Score was first developed in 1967 and is accepted as one of the best used questionnaires dealing the hip function. It is a disease-specific scoring system which was introduced to provide an evaluation system for various hip disabilities and methods of treatment. This Score gives a maximum of 100 points, with domains of pain, function, deformity and motion.
1 secondary outcome
Visual Analog Score
Time frame: 0 - 6 - 12 - 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2010.
- Derived from this study: PubMed 21080920Colen S, van den Bekerom MP, Bellemans J, Mulier M. Comparison of intra-articular injections of hyaluronic acid and corticosteroid in the treatment of osteoarthritis of the hip in comparison with intra-articular injections of bupivacaine. Design of a prospective, randomized, controlled study with blinding of the patients and outcome assessors. BMC Musculoskelet Disord. 2010 Nov 16;11:264. doi: 10.1186/1471-2474-11-264.
Related trials for Coxarthrosis
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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.
Sascha Colen, MD principal investigator
University Hospital Pellenberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Corticosterone in people with Coxarthrosis, run by University Hospital Pellenberg at 1 site in Belgium.
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 8 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: status not confirmed, as of the sponsor's last update on 3 Mar 2010. 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 Belgium. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sascha Colen, MD (0032497180798, sascolen@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: 0 - 6 - 12 - 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01079455, which also lists 1 linked publication.
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 3 Mar 2010.