Fracture; Radius, Lower or Distal EndSHORTNCT04094935
Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability
An observational study of Fracture; Radius, Lower or Distal End, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture; Radius, Lower or Distal End
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2019to Jan 2021
- 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: All consecutive patients operated on for a fractured distal radius with an anterior locked plate in orthopaedic and trauma surgery in Saint Antoine Hospital, Paris
Who may be able to join
- Age ≥ 18 years old
- Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane
- Osteosynthesis by anterior locked plate
- Patient who did not oppose his participation in this research
Who cannot join
- Distal radius fractures with joint refend frontal (posterior marginal)
Trial locations and contacts
1 site in 1 country.
Olivier HERISSON, Dr contact
Marc SOUBEYRAND, Pr contact
France1 site, 1 recruiting
- Recruiting
St Antoine hospital - orthopaedic and traumatic surgery
Paris, 75010
olivier HERISSON, Doctor, olivierherisson@hotmail.com
Marc SOUBEYRAND, Pr, marc.soubeyrand@aphp.fr
About this study
Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.
The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)
Read the detailed description
- Preoperative consultation
- Oral information of the patient of the protocol and delivery of the written information note
- Seeking patient's non-opposition to participating in the study
- Inclusion of the patient
- Surgical procedure for distal radius fracture + immediate post-operative radiography
- Intervention performed according to the usual practices of the service by the surgeon of the day without randomization
- Radiography: 2 shots: face and wrist profile
- Control X-ray + consultation
- Achieved at 3 weeks, 6 weeks and 3 months after the intervention
- X-rays: 2 shots: face and wrist profile
- Control ultrasound o Realized at 3 months after the intervention
End of participation in the study after consultation of 3 months.
- Conditions
- Fracture; Radius, Lower or Distal End
- Keywords
- Fracture of the radius
- Medical subject headings
- Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
Screws exceeding the posterior cortical
Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
Measured: 3 months
Secondary outcomes (3)
Tendon complications
Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
Measured: 3 months
Secondary displacement or dismantling
Proportion of secondary displacement or dismantling 3-month control radio equipment (change of the radial slope on the face and radial glene's anversion on the profile between X-rays at J0 and control x-rays)
Measured: 3 months
Ablation of material or resumption early surgery
Proportion of ablation of material or resumption early surgery on secondary displacement rated at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start11 Oct 2019
- Primary completionOct 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture; Radius, Lower or Distal EndStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier HERISSON, Dr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094935
- Sponsor's protocol ID
- APHP 190158
- Other IDs
- 2019-A00429-48
- Acronym
- SHORT
- Status last verified
- Nov 2019
- First submitted
- 17 Sep 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Plate Osteosynthesis of Fractures of the Lower Extremity of the Radius: Does the Systematic Use of Short Epiphysic Screws Limit the Posterior Protrusion of the Screws Without Compromising Stability
- ClinicalTrials.gov ID
- NCT04094935
- Acronym / sponsor ID
- SHORT / APHP 190158
- Conditions
- Fracture; Radius, Lower or Distal End
- Keywords
- Fracture of the radius
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 19 Sep 2019 (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.
Anterior plate osteosynthesis of fractures of the lower extremity of the radius may be accompanied by tendinous complications : tenosynovitis of extensors or even tendon ruptures caused by the end of the epiphyseai screws.
The intraoperative measurements as well as the realization of the scopic pictures make it possible to estimate the length of the screws but the tendinous lesions remain frequent (5 to 15% according to the various series)
Detailed description
- Preoperative consultation
- Oral information of the patient of the protocol and delivery of the written information note
- Seeking patient's non-opposition to participating in the study
- Inclusion of the patient
- Surgical procedure for distal radius fracture + immediate post-operative radiography
- Intervention performed according to the usual practices of the service by the surgeon of the day without randomization
- Radiography: 2 shots: face and wrist profile
- Control X-ray + consultation
- Achieved at 3 weeks, 6 weeks and 3 months after the intervention
- X-rays: 2 shots: face and wrist profile
- Control ultrasound o Realized at 3 months after the intervention
End of participation in the study after consultation of 3 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients operated on for a fractured distal radius with an anterior locked plate in orthopaedic and trauma surgery in Saint Antoine Hospital, Paris
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Fracture (s) of extra joint distal radius with or without joint refend in the sagitta plane
- Osteosynthesis by anterior locked plate
- Patient who did not oppose his participation in this research
Key exclusion criteria (1 listed)
- Distal radius fractures with joint refend frontal (posterior marginal)
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
Screws exceeding the posterior cortical
Time frame: 3 months
Proportion of tendon complications induced by conflict between the distal end of the epiphysal screws and extender tendons: rupture, tenosynovitis.
3 secondary outcomes
Tendon complications
Time frame: 3 months
Secondary displacement or dismantling
Time frame: 3 months
Ablation of material or resumption early surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Fracture; Radius, Lower or Distal End
Not yet recruiting
Use of a Vibration Tool for Postoperative Pain Control in Distal Radius Fractures
Distal Radius Fracture, Radius Fracture Distal
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.
Olivier HERISSON, Dr contact
Marc SOUBEYRAND, Pr contact
Olivier HERISSON, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
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 Fracture; Radius, Lower or Distal End, run by Assistance Publique - Hôpitaux de 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 4 inclusion and 1 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 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier HERISSON, Dr (olivierherisson@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screws exceeding the posterior cortical (time frame: 3 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 18 Nov 2019.