Distal Radius Fracture70NCT02154620
Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster
A study testing Volar plate and Synthes TCP volar plate in people with Distal Radius Fracture, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Volar plate and Synthes TCP volar plate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2013to 31 Jan 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
- Low energy injury
- Patient 70 years old or older
- 72 hours or less since injury at time of diagnosis
- Patient registered in the Stockholm region
- Patient understands spoken and written swedish
Who cannot join
- Intraarticular displacement in radiocarpal joint of more than 1 mm
- Ulna fractured proximal to the base of the styloid process of ulna
- Earlier unilateral functional impairment of hand/wrist
- Injury to tendon, nerve or skin besides the fracture
- Rheumatoid arthritis or other severe systemic joint disease
- Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
- Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
- Medical illness that makes general anesthesia impossible
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopaedics, Stockholm South Hospital
Stockholm, 11883
About this study
Official title: Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.
An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.
A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
- Conditions
- Distal Radius Fracture
- Being tested
- Volar plate, Synthes TCP volar plate
- Keywords
- Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volar plateProcedure or surgery
Also called Synthes TCP volar plate for distal radius
An anatomically countoured volar plate is implanted through a Henry's incision.
Synthes TCP volar plateDevice
| Study group | Role | What they receive |
|---|---|---|
| Plaster cast | No intervention | The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist |
| Volar plate | Experimental | The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery. Receives: Procedure: Volar plate; Device: Synthes TCP volar plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient related wrist evaluation (PRWE)
Measured: 52 weeks
Secondary outcomes (1)
Patient related wrist evaluation (PRWE)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionJan 2018
- Study completion31 Jan 2018
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.
- More trials run by Karolinska InstitutetThe 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sari Ponzer, Karolinska Institutet
- Investigators
- Anders Enocson, M.D, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154620
- Sponsor's protocol ID
- 70
- Acronym
- 70
- Status last verified
- Mar 2021
- First submitted
- 2 May 2014
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
PubMed 35549696
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02154620
- Acronym / sponsor ID
- 70 / 70
- Conditions
- Distal Radius Fracture
- Keywords
- Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 3 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.
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.
An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.
A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaster cast | No intervention | –The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist |
| Volar plate | Experimental | Procedure: Volar plate, Device: Synthes TCP volar plateThe patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
- Low energy injury
- Patient 70 years old or older
- 72 hours or less since injury at time of diagnosis
- Patient registered in the Stockholm region
Key exclusion criteria (8 listed)
- Intraarticular displacement in radiocarpal joint of more than 1 mm
- Ulna fractured proximal to the base of the styloid process of ulna
- Earlier unilateral functional impairment of hand/wrist
- Injury to tendon, nerve or skin besides the fracture
- Rheumatoid arthritis or other severe systemic joint disease
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 |
|---|---|---|
| Volar plateAlso: Synthes TCP volar plate for distal radiusAn anatomically countoured volar plate is implanted through a Henry's incision. | Procedure or surgery | Volar plate |
| Synthes TCP volar plate | Device | Volar plate |
Primary outcome
Patient related wrist evaluation (PRWE)
Time frame: 52 weeks
1 secondary outcome
Patient related wrist evaluation (PRWE)
Time frame: 3 years
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 15 Mar 2021.
- Derived from this study: PubMed 35549696Sudow H, Severin S, Wilcke M, Saving J, Skoldenberg O, Navarro CM. Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years - a three year follow-up of a randomized controlled trial. BMC Musculoskelet Disord. 2022 May 12;23(1):447. doi: 10.1186/s12891-022-05394-7.
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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.
Anders Enocson, M.D, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volar plate and Synthes TCP volar plate in people with Distal Radius Fracture, run by Karolinska Institutet at 1 site in Sweden.
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 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: finished, as of the sponsor's last update on 15 Mar 2021. 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 Sweden. 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?
Patient related wrist evaluation (PRWE) (time frame: 52 weeks). 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 NCT02154620, 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 15 Mar 2021.