Pertrochanter FracturePAVONCT02171897
Pertrochanter Arthroplasty Versus Osteosynthesis
A study testing Osteosynthesis and Total hip replacement in people with Pertrochanter Fracture, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Pertrochanter Fracture
- What is being tested?
- Osteosynthesis and Total hip replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jan 2015to 21 Oct 2018
- 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 70 years and older
- All sexes
- Older adult
Who may be able to join
- Patients who have provided written informed consent
- Patients over 18 years old
- Patients less than 70 years old
- Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)
Who cannot join
- Adult under guardianship
- Patients not covered by national health insurance
- Pregnant or breast-feeding women
- Unable to walk independently before the trauma
- Patients with dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.
The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.
The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.
- Conditions
- Pertrochanter Fracture
- Being tested
- Osteosynthesis, Total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsteosynthesisProcedure or surgery
Total hip replacementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with osteosynthesis | Experimental | Not described Receives: Procedure: Osteosynthesis |
| Patients treated with total hip replacement | Experimental | Not described Receives: Procedure: Total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Score
Functional hip score
Measured: At 6 months after surgery
Secondary outcomes (6)
PMA functional score
Functional score
Measured: Up to 1 year after surgery
Time to recovery of weight-bearing
Measured: Up to 1 year after surgery
Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking)
Measured: Up to 1 year after surgery
Parker score
Score autonomy
Measured: Up to 1 year after surgery
Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism)
Measured: Up to 1 year after surgery
Death rate
Measured: Up to 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start29 Jan 2015
- Primary completion21 Oct 2018
- Study completion21 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertrochanter FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171897
- Sponsor's protocol ID
- TREMLET AOI 2013
- Acronym
- PAVO
- Status last verified
- Sep 2019
- First submitted
- 18 Jun 2014
- Last updated
- 4 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
- ClinicalTrials.gov ID
- NCT02171897
- Acronym / sponsor ID
- PAVO / TREMLET AOI 2013
- Conditions
- Pertrochanter Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 29 Jan 2015 (actual)
- Primary completion
- 21 Oct 2018 (actual)
- Study completion
- 21 Oct 2018 (actual)
- First posted
- 24 Jun 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.
This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.
The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.
The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with osteosynthesis | Experimental | Procedure: Osteosynthesis |
| Patients treated with total hip replacement | Experimental | Procedure: Total hip replacement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who have provided written informed consent
- Patients over 18 years old
- Patients less than 70 years old
- Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)
Key exclusion criteria (5 listed)
- Adult under guardianship
- Patients not covered by national health insurance
- Pregnant or breast-feeding women
- Unable to walk independently before the trauma
- Patients with dementia
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 |
|---|---|---|
| Osteosynthesis | Procedure or surgery | Patients treated with osteosynthesis |
| Total hip replacement | Procedure or surgery | Patients treated with total hip replacement |
Primary outcome
Harris Score
Time frame: At 6 months after surgery
Functional hip score
6 secondary outcomes
PMA functional score
Time frame: Up to 1 year after surgery
Time to recovery of weight-bearing
Time frame: Up to 1 year after surgery
Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking)
Time frame: Up to 1 year after surgery
Parker score
Time frame: Up to 1 year after surgery
Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism)
Time frame: Up to 1 year after surgery
Death rate
Time frame: Up to 1 year after surgery
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 4 Sep 2019.
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 Osteosynthesis and Total hip replacement in people with Pertrochanter Fracture, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 5 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 4 Sep 2019. 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?
Harris Score (time frame: At 6 months 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 4 Sep 2019.