Distal Radius FractureNCT02879656
Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years
A study testing non-operative treatment and operative treatment in people with Distal Radius Fracture, run by Tampere University Hospital at 5 sites in 3 countries.
Trial summary
The present collaboration study on the treatment of distal radius fractures is aimed to: (i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE (ii) to compare non-operative… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- non-operative treatment and operative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 291 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 23 Feb 2018to 6 Jun 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
- >10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph
Who cannot join
- Refuse to participate the study
- Open fracture more than Gustilo 1 gradus
- Age under 65 years
- Chauffeure's or Barton´s fracture
- Smith´s fracture (volar angulation of the fracture)
- Does not understand written and spoken guidance in local languages
- Pathological fracture or previous fracture in the same wrist or forearm
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Finland3 sites
Jyväskylä Central Hospital
Jyväskylä
Pori Central Hospital
Pori
Tampere University Hospital
Tampere, 33820
About this study
Official title: Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial
The present collaboration study on the treatment of distal radius fractures is aimed to:
(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE
Read more
(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE
(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture
(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture
(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures
(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome
(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS
- Conditions
- Distal Radius Fracture
- Being tested
- non-operative treatment, operative treatment
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-operative treatmentProcedure or surgery
conservative treatment with 5 weeks cast immobilization
operative treatmentProcedure or surgery
surgery with volar locking plate with modified Henry's volar approach
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | Early ustable fracture:
Phase 1:
After closed reduction, if satisfactory reduction is not achieved fulfilling the inclusion criteria, the patient is allocated to Cohort 1. The patient is randomized to either non-operative (=Arm 1) or operative treatment (=Arm 2). Patients allocated to non-operative treatment will undergo a standard treatment protocol. Patients allocated to operative treatment will undergo a surgery with volar locking plate with modified Henry's volar approach. Receives: Procedure: non-operative treatment; Procedure: operative treatment |
| Cohort 2 | Other | Early stable fracture:
Phase 1:
After closed reduction, if satisfactory position is achieved, the patient is allocated to Cohort 2 and conservative treatment is performed as usually.
Phase 2:
Patients allocated to Cohort 2, will visit orthopedic outpatient clinic in 1 week in the hospital where the treatment was initially started. If reduction is maintained the patient will undergo standard follow-up visits. If reduction is lost to fulfill the inclusion criteria for surgery the patient is asked to participate to phase 2 of this study. After the patient´s enrollment has been confirmed and informed consent is signed, the patient is randomized to either non-operative (=Arm 3N) or operative treatment (=Arm 3O). If allocated to non-operative treatment patient will undergo the same protocol as those in the Arm 1. Patients allocated to operative treatment will undergo surgery with volar locking plate with standard volar approach. Receives: Procedure: non-operative treatment; Procedure: operative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time in Patient Rated Wrist Evaluation (PRWE)
PRWE is the primary outcome measure of wrist pain and disability in the study.
The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
Measured: 3 months, 1 year, 2 years
Secondary outcomes (9)
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire
The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale.
Measured: 3 months, 1 year, 2 years
Quality of life measured with the 15-D
The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale.
Measured: Baseline, 3 months, 1 year, 2 years
Pain measured in Visual Analogue Scale (VAS)
The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain.
Measured: 3 months, 1 year, 2 years
Grip strength measured with a dynamometer
Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side.
Measured: 3 months, 1 year
Pain catastrophizing measured with the pain catastrophizing scale (PCS)
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire. The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain.
Measured: baseline, 3 months, 1 year, 2 years
Physical activity measured with Axivity accelerometer
Physical activity will be measured in a subgroup of patients in two separate follow-up time points.
Measured: 3 months, 1 year
Self-assessment
Patient's self-assessment questionnaire will be analyzed to find out which parameters are of most importance for the patient.
Measured: Baseline, 1 year, 2 years
EWC
Edinbourgh wrist calculator will be used to estimate the propability of loss of reduction during the follow-up.
Measured: Baseline
Frailty
Clinical Frailty Score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start23 Feb 2018
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Tampere University HospitalThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District, Satakunta Central Hospital, Regionshospitalet Viborg, Skive
- Responsible party
- Principal investigator, Antti Launonen, Tampere University Hospital
- Investigators
- Ville Mattila, Prof, Study director, Tampere University HospitalAntti Launonen, MD, Principal investigator, Tampere University HospitalMinna Laitinen, adjunct prof, Study chair, Tampere University HospitalTeemu Hevonkorpi, MD, Study chair, Tampere University HospitalLauri Raittio, MD, Study chair, Tampere University HospitalToni Luokkala, MD, Study chair, Central Finland Hospital DistrictAleksi Reito, MD, Study chair, Central Finland Hospital DistrictJuha Kukkonen, MD, Study chair, Satakunta Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879656
- Sponsor's protocol ID
- R16105
- Status last verified
- Apr 2025
- First submitted
- 17 Aug 2016
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hevonkorpi TP, Launonen AP, Reito A, Schandorff Skjaerbaek M, Li Y, Luokkala T, Kukkonen J, Paloneva J, Kvistgaard Ostergaard H, Fellander-Tsai L, Laitinen MK, Sumrein BO, Mechlenburg I, Mattila VM; as the NITEP Group (Nordic Innovative Trial to Evaluate osteoPorotic fractures). Nonoperative treatment versus volar locking plating for distal radius fracture in patients aged 65 years or older (DRIFT trial): A randomized controlled trial. PLoS Med. 2025 Sep 5;22(9):e1004728. doi: 10.1371/journal.pmed.1004728. eCollection 2025 Sep.
PubMed 40911648Hevonkorpi TP, Launonen AP, Raittio L, Luokkala T, Kukkonen J, Reito A, Sumrein BO, Laitinen MK, Mattila VM; NITEP-group. Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over - a study protocol for a prospective, randomized controlled trial. BMC Musculoskelet Disord. 2018 Apr 5;19(1):106. doi: 10.1186/s12891-018-2019-5.
PubMed 29621979
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02879656
- Acronym / sponsor ID
- R16105
- Conditions
- Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District, Satakunta Central Hospital, Regionshospitalet Viborg, Skive
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 26 Aug 2016 (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.
The present collaboration study on the treatment of distal radius fractures is aimed to:
(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE
(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE
(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture
(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture
(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures
(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome
(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Procedure: non-operative treatment, Procedure: operative treatmentEarly ustable fracture: Phase 1: After closed reduction, if satisfactory reduction is not achieved fulfilling the inclusion criteria, the patient is allocated to Cohort 1. The patient is randomized to either non-operative (=Arm 1) or operative treatment (=Arm 2). Patients allocated to non-operative treatment will undergo a standard treatment protocol. Patients allocated to operative treatment will undergo a surgery with volar locking plate with modified Henry's volar approach. |
| Cohort 2 | Other | Procedure: non-operative treatment, Procedure: operative treatmentEarly stable fracture: Phase 1: After closed reduction, if satisfactory position is achieved, the patient is allocated to Cohort 2 and conservative treatment is performed as usually. Phase 2: Patients allocated to Cohort 2, will visit orthopedic outpatient clinic in 1 week in the hospital where the treatment was initially started. If reduction is maintained the patient will undergo standard follow-up visits. If reduction is lost to fulfill the inclusion criteria for surgery the patient is asked to participate to phase 2 of this study. After the patient´s enrollment has been confirmed and informed consent is signed, the patient is randomized to either non-operative (=Arm 3N) or operative treatment (=Arm 3O). If allocated to non-operative treatment patient will undergo the same protocol as those in the Arm 1. Patients allocated to operative treatment will undergo surgery with volar locking plate with standard volar approach. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
- >10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph
Key exclusion criteria (7 listed)
- Refuse to participate the study
- Open fracture more than Gustilo 1 gradus
- Age under 65 years
- Chauffeure's or Barton´s fracture
- Smith´s fracture (volar angulation of the fracture)
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 |
|---|---|---|
| non-operative treatmentconservative treatment with 5 weeks cast immobilization | Procedure or surgery | Cohort 1, Cohort 2 |
| operative treatmentsurgery with volar locking plate with modified Henry's volar approach | Procedure or surgery | Cohort 1, Cohort 2 |
Primary outcome
Change over time in Patient Rated Wrist Evaluation (PRWE)
Time frame: 3 months, 1 year, 2 years
PRWE is the primary outcome measure of wrist pain and disability in the study. The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.
9 secondary outcomes
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire
Time frame: 3 months, 1 year, 2 years
Quality of life measured with the 15-D
Time frame: Baseline, 3 months, 1 year, 2 years
Pain measured in Visual Analogue Scale (VAS)
Time frame: 3 months, 1 year, 2 years
Grip strength measured with a dynamometer
Time frame: 3 months, 1 year
Pain catastrophizing measured with the pain catastrophizing scale (PCS)
Time frame: baseline, 3 months, 1 year, 2 years
Physical activity measured with Axivity accelerometer
Time frame: 3 months, 1 year
Self-assessment
Time frame: Baseline, 1 year, 2 years
EWC
Time frame: Baseline
Frailty
Time frame: Baseline
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 30 Apr 2025.
- Derived from this study: PubMed 40911648Hevonkorpi TP, Launonen AP, Reito A, Schandorff Skjaerbaek M, Li Y, Luokkala T, Kukkonen J, Paloneva J, Kvistgaard Ostergaard H, Fellander-Tsai L, Laitinen MK, Sumrein BO, Mechlenburg I, Mattila VM; as the NITEP Group (Nordic Innovative Trial to Evaluate osteoPorotic fractures). Nonoperative treatment versus volar locking plating for distal radius fracture in patients aged 65 years or older (DRIFT trial): A randomized controlled trial. PLoS Med. 2025 Sep 5;22(9):e1004728. doi: 10.1371/journal.pmed.1004728. eCollection 2025 Sep.
- Derived from this study: PubMed 29621979Hevonkorpi TP, Launonen AP, Raittio L, Luokkala T, Kukkonen J, Reito A, Sumrein BO, Laitinen MK, Mattila VM; NITEP-group. Nordic Innovative Trial to Evaluate OsteoPorotic Fractures (NITEP-group): non-operative treatment versus surgery with volar locking plate in the treatment of distal radius fracture in patients aged 65 and over - a study protocol for a prospective, randomized controlled trial. BMC Musculoskelet Disord. 2018 Apr 5;19(1):106. doi: 10.1186/s12891-018-2019-5.
- Individual participant dataSharing planned: No
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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.
Ville Mattila, Prof study director
Tampere University Hospital
Antti Launonen, MD principal investigator
Tampere University Hospital
Minna Laitinen, adjunct prof study chair
Tampere University Hospital
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-operative treatment and operative treatment in people with Distal Radius Fracture, run by Tampere University Hospital at 5 sites in 3 countries.
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 2 inclusion and 7 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 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland, Denmark, 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?
Change over time in Patient Rated Wrist Evaluation (PRWE) (time frame: 3 months, 1 year, 2 years). 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 NCT02879656, which also lists 2 linked publications.
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 30 Apr 2025.