Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years
NCT ID: NCT02879656
Last Updated: 2025-04-30
Study Results
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Basic Information
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COMPLETED
NA
291 participants
INTERVENTIONAL
2018-02-23
2023-06-06
Brief Summary
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(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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
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.
non-operative treatment
conservative treatment with 5 weeks cast immobilization
operative treatment
surgery with volar locking plate with modified Henry's volar approach
Cohort 2
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.
non-operative treatment
conservative treatment with 5 weeks cast immobilization
operative treatment
surgery with volar locking plate with modified Henry's volar approach
Interventions
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non-operative treatment
conservative treatment with 5 weeks cast immobilization
operative treatment
surgery with volar locking plate with modified Henry's volar approach
Eligibility Criteria
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Inclusion Criteria
* \>10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Central Finland Hospital District
OTHER
Satakunta Central Hospital
OTHER
Regionshospitalet Viborg, Skive
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Antti Launonen
MD, PhD
Principal Investigators
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Ville Mattila, Prof
Role: STUDY_DIRECTOR
Tampere University Hospital
Antti Launonen, MD
Role: PRINCIPAL_INVESTIGATOR
Tampere University Hospital
Minna Laitinen, adjunct prof
Role: STUDY_CHAIR
Tampere University Hospital
Teemu Hevonkorpi, MD
Role: STUDY_CHAIR
Tampere University Hospital
Lauri Raittio, MD
Role: STUDY_CHAIR
Tampere University Hospital
Toni Luokkala, MD
Role: STUDY_CHAIR
Central Finland Central Hospital
Aleksi Reito, MD
Role: STUDY_CHAIR
Central Finland Central Hospital
Juha Kukkonen, MD
Role: STUDY_CHAIR
Satakunta Central Hospital
Li Felländer-Tsai, MD
Role: STUDY_CHAIR
Karolinska University Hospital
Locations
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Viborg Regional Hospital
Viborg, , Denmark
Jyväskylä Central Hospital
Jyväskylä, , Finland
Pori Central Hospital
Pori, , Finland
Tampere University Hospital
Tampere, , Finland
Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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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.
Hevonkorpi 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.
Other Identifiers
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R16105
Identifier Type: -
Identifier Source: org_study_id
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