Hip ArthroplastyAYNFNCT01520961
Functional Recovery After Partial Hip Arthroplasty: Anterior or Posterolateral Approach?
An observational study of Hip Arthroplasty and Femoral Neck Fractures, run by Hospital Ambroise Paré Paris at 1 site in France.
Trial summary
Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthroplasty, Femoral Neck Fractures
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Mar 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Partial Hip Arthroplasty for Femoral Neck Fracture
Who may be able to join
- Femoral Neck Fracture
- Partial Hip Arthroplasty
Who cannot join
- Total Hip Arthroplasty
- Osteosynthesis
- Pathologic fracture
Trial locations and contacts
1 site in 1 country.
France1 site
Ambroise Paré Hospital. Orthopaedic surgery department
Boulogne-Billancourt, Île-de-France Region, 92100
About this study
Official title: Approach Your Neck Fracture
Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.
The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.
- Conditions
- Hip Arthroplasty, Femoral Neck Fractures
- Keywords
- Partial Hip Arthroplasty
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hueter Anterior Approach | Not described | |
| posterolateral approach | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of mobility
Efficacity issue
Measured: Timed Get Up and Go Test at six weeks
Secondary outcomes (2)
Measurement of mobility
Measured: Using 2 cruches or walker at 6 weeks after surgery
Dislocation rate
Measured: At 6 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520961
- Sponsor's protocol ID
- APR122011
- Acronym
- AYNF
- Status last verified
- Feb 2015
- First submitted
- 19 Jan 2012
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approach Your Neck Fracture
- ClinicalTrials.gov ID
- NCT01520961
- Acronym / sponsor ID
- AYNF / APR122011
- Conditions
- Hip Arthroplasty, Femoral Neck Fractures
- Keywords
- Partial Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Jan 2012 (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.
Hueter anterior approach as described by Siguier allows an anatomical approach without muscle or tendon sections. It minimizes the rate of dislocation after primary total hip arthroplasty (1.5%, Sariali)and seems to allow quicker rehabilitation.
The investigators hypothesis was Hueter anterior approach allows quicker functional recovery after partial hip replacement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hueter Anterior Approach | – | – |
| posterolateral approach | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Partial Hip Arthroplasty for Femoral Neck Fracture
Key inclusion criteria (2 listed)
- Femoral Neck Fracture
- Partial Hip Arthroplasty
Key exclusion criteria (3 listed)
- Total Hip Arthroplasty
- Osteosynthesis
- Pathologic fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of mobility
Time frame: Timed Get Up and Go Test at six weeks
Efficacity issue
2 secondary outcomes
Measurement of mobility
Time frame: Using 2 cruches or walker at 6 weeks after surgery
Dislocation rate
Time frame: At 6 weeks postoperatively
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 9 Feb 2015.
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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?
An observational study of Hip Arthroplasty and Femoral Neck Fractures, run by Hospital Ambroise Paré Paris 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 2 inclusion and 3 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 9 Feb 2015. 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 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?
Measurement of mobility (time frame: Timed Get Up and Go Test at six weeks). 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 9 Feb 2015.