Distal Intra-articular Radius Fracture With a Dorsal TiltPAPPONCT03259906
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
A study testing DASH score, X-ray and posterior osteosynthesis in people with Distal Intra-articular Radius Fracture With a Dorsal Tilt, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Distal Intra-articular Radius Fracture With a Dorsal Tilt
- What is being tested?
- DASH score, X-ray and posterior osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to 4 Jul 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have provided written informed consent
- Patients older than 45 years
- Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)
Who cannot join
- Adults under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Patients presenting other injuries in the same upper limb
- Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)
- Pre-trauma paralysis of the limb
- Open fracture
- Fracture with palmer tilt or extra-articular
Trial locations and contacts
1 site in 1 country.
About this study
For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.
First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.
In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.
- Being tested
- DASH score, X-ray, posterior osteosynthesis, Anterior osteosynthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH scoreOther
Questionnaire asking about Disability of Arm, Shoulder and Hand
X-rayProcedure or surgery
postoperative x-rays at 6 weeks, 3, 6 and 12 months
posterior osteosynthesisProcedure or surgery
Osteosynthesis using a posterior plate
Anterior osteosynthesisProcedure or surgery
Osteosynthesis using an anterior plate
| Study group | Role | What they receive |
|---|---|---|
| Osteosynthesis using a posterior plate | Active comparator | Not described Receives: Other: DASH score; Procedure: X-ray; Procedure: posterior osteosynthesis |
| Osteosynthesis using an anterior plate | Active comparator | Not described Receives: Other: DASH score; Procedure: X-ray; Procedure: Anterior osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of functional recovery using the DASH questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study startJan 2017
- Primary completion4 Jul 2018
- Study completion4 Jul 2018
Why it stopped: Lack of performance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Intra-articular Radius Fracture With a Dorsal TiltStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03259906
- Sponsor's protocol ID
- ALVERNHE LABATTUT 2016
- Acronym
- PAPPO
- Status last verified
- Feb 2024
- First submitted
- 21 Aug 2017
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate
- ClinicalTrials.gov ID
- NCT03259906
- Acronym / sponsor ID
- PAPPO / ALVERNHE LABATTUT 2016
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of performance
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 4 Jul 2018 (actual)
- First posted
- 24 Aug 2017 (actual)
- 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.
For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.
First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.
In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteosynthesis using a posterior plate | Active comparator | Other: DASH score, Procedure: X-ray, Procedure: posterior osteosynthesis |
| Osteosynthesis using an anterior plate | Active comparator | Other: DASH score, Procedure: X-ray, Procedure: Anterior osteosynthesis |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have provided written informed consent
- Patients older than 45 years
- Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)
Key exclusion criteria (8 listed)
- Adults under guardianship
- Patients without national health insurance cover
- Pregnant or breast-feeding women
- Patients presenting other injuries in the same upper limb
- Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)
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 |
|---|---|---|
| DASH scoreQuestionnaire asking about Disability of Arm, Shoulder and Hand | Other | Osteosynthesis using a posterior plate, Osteosynthesis using an anterior plate |
| X-raypostoperative x-rays at 6 weeks, 3, 6 and 12 months | Procedure or surgery | Osteosynthesis using a posterior plate, Osteosynthesis using an anterior plate |
| posterior osteosynthesisOsteosynthesis using a posterior plate | Procedure or surgery | Osteosynthesis using a posterior plate |
| Anterior osteosynthesisOsteosynthesis using an anterior plate | Procedure or surgery | Osteosynthesis using an anterior plate |
Primary outcome
Evaluation of functional recovery using the DASH questionnaire
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of performance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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 DASH score, X-ray and posterior osteosynthesis in people with Distal Intra-articular Radius Fracture With a Dorsal Tilt, 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 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 22 Feb 2024. 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 (reason given: Lack of performance). 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?
Evaluation of functional recovery using the DASH questionnaire (time frame: 6 months). 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 22 Feb 2024.