Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years

NCT02879656 | Completed

• 1 other identifier: R16105
• Study Type: interventional
• Target: 291
• Locations: 3 countries
• Sites: 5

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  3 months, 1 year, 2 years

• Quality of life measured with the 15-D

  Baseline, 3 months, 1 year, 2 years

• Pain measured in Visual Analogue Scale (VAS)

  3 months, 1 year, 2 years

• Grip strength measured with a dynamometer

  3 months, 1 year

• Pain catastrophizing measured with the pain catastrophizing scale (PCS)

  baseline, 3 months, 1 year, 2 years

Study Arms (2)

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.

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.

Procedure: non-operative treatment; Procedure: operative treatment

Interventions

non-operative treatment PROCEDURE

conservative treatment with 5 weeks cast immobilization

Cohort 1; Cohort 2

operative treatment PROCEDURE

surgery with volar locking plate with modified Henry's volar approach

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Central Finland Hospital District: collaborator
• Satakunta Central Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator

Study Sites (5)

Viborg Regional Hospital

Viborg, Denmark

Location

Jyväskylä Central Hospital

Jyväskylä, Finland

Location

Pori Central Hospital

Pori, Finland

Location

Tampere University Hospital

Tampere, 33820, Finland

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (2)

• 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.

  PMID: 40911648 DERIVED

• 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.

  PMID: 29621979 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Ville Mattila, Prof

  Tampere University Hospital

  STUDY DIRECTOR

• Antti Launonen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• Minna Laitinen, adjunct prof

  Tampere University Hospital

  STUDY CHAIR

• Teemu Hevonkorpi, MD

  Tampere University Hospital

  STUDY CHAIR

• Lauri Raittio, MD

  Tampere University Hospital

  STUDY CHAIR

• Toni Luokkala, MD

  Central Finland Central Hospital

  STUDY CHAIR

• Aleksi Reito, MD

  Central Finland Central Hospital

  STUDY CHAIR

• Juha Kukkonen, MD

  Satakunta Central Hospital

  STUDY CHAIR

• Li Felländer-Tsai, MD

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 26, 2016
• Study Start: February 23, 2018
• Primary Completion: June 6, 2023
• Study Completion: June 6, 2023
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); FI (3); SE (1)