Distal Radius FractureNCT05690477
Corrective Osteotomy of the Distal Radius Without Bone Grafting
An observational study of Distal Radius Fracture, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Corrective osteotomy of the distal radius
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2009to 31 Dec 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients with extraarticular corrective osteotomy of the distal radius without cortical contact and without the use of bone graft due to a malunited distal radius fracture
Who may be able to join
- malunited distal radius fracture
- extraarticular corrective osteotomy
- palmar approach
- no bone graft used
- no cortical contact after dorsal open wedge osteotomy
- signed informed consent
Who cannot join
- others reasons for malunion
- intraarticular corrective osteotomy
- use of a bone graft
- cortical contact after open wedge osteotomy
- lost to follow up
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hand, Plastic and Reconstructive Surgery
Sankt Gallen, 9007
About this study
Official title: Corrective Osteotomy of the Distal Radius With Palmar Locking Plate Osteosynthesis Without Bone Grafting and Without Cortical Contact
The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy.
The goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.
- Conditions
- Distal Radius Fracture
- Being tested
- Corrective osteotomy of the distal radius
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrective osteotomy of the distal radiusProcedure or surgery
Corrective osteotomy of the distal radius with a palmar locking plate osteosynthesis without the use of a bone graft and without cortical contact.
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary fracture dislocation
Measured: 1 year
complete bone healing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Jan 2009
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vilijam Zdravkovic, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690477
- Sponsor's protocol ID
- 27012022
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fuchs J, Spuhler DL, Luz S, Zdravkovic V, Hainich J. Corrective osteotomy of the distal radius with palmar locking plate osteosynthesis without bone grafting and without cortical contact. J Hand Surg Eur Vol. 2024 Mar;49(3):359-365. doi: 10.1177/17531934231179875. Epub 2023 Jun 13.
PubMed 37310077
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrective Osteotomy of the Distal Radius With Palmar Locking Plate Osteosynthesis Without Bone Grafting and Without Cortical Contact
- ClinicalTrials.gov ID
- NCT05690477
- Acronym / sponsor ID
- 27012022
- Conditions
- Distal Radius Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jan 2023 (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.
The investigators retrospectively analyzed patients who underwent extraarticular corrective osteotomy of the distal radius via a palmar approach and without the use of a bone graft, even in the absence of cortical contact after corrective osteotomy.
The goal of this retrospective observational study is to determine whether secondary dislocation or nonunion occurs after corrective osteotomy without bone grafting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with extraarticular corrective osteotomy of the distal radius without cortical contact and without the use of bone graft due to a malunited distal radius fracture
Key inclusion criteria (6 listed)
- malunited distal radius fracture
- extraarticular corrective osteotomy
- palmar approach
- no bone graft used
- no cortical contact after dorsal open wedge osteotomy
Key exclusion criteria (5 listed)
- others reasons for malunion
- intraarticular corrective osteotomy
- use of a bone graft
- cortical contact after open wedge osteotomy
- lost to follow 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 |
|---|---|---|
| Corrective osteotomy of the distal radiusCorrective osteotomy of the distal radius with a palmar locking plate osteosynthesis without the use of a bone graft and without cortical contact. | Procedure or surgery | – |
Primary outcome
Secondary fracture dislocation
Time frame: 1 year
complete bone healing
Time frame: 1 year
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 23 Jan 2023.
- Derived from this study: PubMed 37310077Fuchs J, Spuhler DL, Luz S, Zdravkovic V, Hainich J. Corrective osteotomy of the distal radius with palmar locking plate osteosynthesis without bone grafting and without cortical contact. J Hand Surg Eur Vol. 2024 Mar;49(3):359-365. doi: 10.1177/17531934231179875. Epub 2023 Jun 13.
- Individual participant dataSharing planned: No
Related trials for Distal Radius Fracture
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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 Distal Radius Fracture, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
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 6 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 23 Jan 2023. 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 Switzerland. 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?
Secondary fracture dislocation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690477, which also lists 1 linked publication.
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 23 Jan 2023.