Hip ArthritisNCT00894218
New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty
A study testing Arthroplasty in people with Hip Arthritis and Knee Arthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hip Arthritis, Knee Arthritis
- What is being tested?
- Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight < 100 kg
- score UCLA > 4
- prosthesis of first intention
Who cannot join
- Pregnant
- score UCLA < 4
- osteotomy near to prosthesis
- prosthesis requiring an osseous transplant
- prosthesis already set up
- infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis
- neuromuscular diseases able to perturb walking or staying
- congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon
Trial locations and contacts
1 site in 1 country.
About this study
Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.
- Conditions
- Hip Arthritis, Knee Arthritis
- Being tested
- Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroplastyProcedure or surgery
Hip or knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Conventional arthroplasty | Active comparator | Total hip or knee conventional arthroplasty Receives: Procedure: Arthroplasty |
| Mini-invasive arthroplasty | Experimental | Total hip or knee mini-invasive arthroplasty Receives: Procedure: Arthroplasty |
| Mini-invasive and computer-assisted arthroplasty | Experimental | Mini-invasive and computer-assisted total hip or knee arthroplasty Receives: Procedure: Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques
Measured: 2 years after surgery
Secondary outcomes (1)
Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894218
- Sponsor's protocol ID
- 2007-26
- Other IDs
- 2007-A0084845
- Status last verified
- Feb 2014
- First submitted
- 4 May 2009
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty
- ClinicalTrials.gov ID
- NCT00894218
- Acronym / sponsor ID
- 2007-26
- Conditions
- Hip Arthritis, Knee Arthritis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 6 May 2009 (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.
Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional arthroplasty | Active comparator | Procedure: ArthroplastyTotal hip or knee conventional arthroplasty |
| Mini-invasive arthroplasty | Experimental | Procedure: ArthroplastyTotal hip or knee mini-invasive arthroplasty |
| Mini-invasive and computer-assisted arthroplasty | Experimental | Procedure: ArthroplastyMini-invasive and computer-assisted total hip or knee arthroplasty |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Weight < 100 kg
- score UCLA > 4
- prosthesis of first intention
Key exclusion criteria (8 listed)
- Pregnant
- score UCLA < 4
- osteotomy near to prosthesis
- prosthesis requiring an osseous transplant
- prosthesis already set up
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 |
|---|---|---|
| ArthroplastyHip or knee arthroplasty | Procedure or surgery | Conventional arthroplasty, Mini-invasive and computer-assisted arthroplasty, Mini-invasive arthroplasty |
Primary outcome
To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques
Time frame: 2 years after surgery
1 secondary outcome
Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs
Time frame: 2 years after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroplasty in people with Hip Arthritis and Knee Arthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 25 Feb 2014. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques (time frame: 2 years after surgery). 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 25 Feb 2014.