Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years
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| ClinicalTrials.gov Identifier: NCT02879656 |
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Recruitment Status :
Completed
First Posted : August 26, 2016
Last Update Posted : May 14, 2024
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Distal Radius Fracture | Procedure: non-operative treatment Procedure: operative treatment | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 277 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 23, 2018 |
| Actual Primary Completion Date : | June 6, 2023 |
| Actual Study Completion Date : | June 6, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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. |
Procedure: non-operative treatment
conservative treatment with 5 weeks cast immobilization Procedure: operative treatment surgery with volar locking plate with modified Henry's volar approach |
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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. |
Procedure: non-operative treatment
conservative treatment with 5 weeks cast immobilization Procedure: operative treatment surgery with volar locking plate with modified Henry's volar approach |
- 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.
- Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire [ Time Frame: 3 months, 1 year, 2 years ]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.
- Quality of life measured with the 15-D [ Time Frame: Baseline, 3 months, 1 year, 2 years ]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.
- Pain measured in Visual Analogue Scale (VAS) [ Time Frame: 3 months, 1 year, 2 years ]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.
- Grip strength measured with a dynamometer [ Time Frame: 3 months, 1 year ]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.
- Pain catastrophizing measured with the pain catastrophizing scale (PCS) [ Time Frame: baseline, 3 months, 1 year, 2 years ]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.
- Physical activity measured with Axivity accelerometer [ Time Frame: 3 months, 1 year ]Physical activity will be measured in a subgroup of patients in two separate follow-up time points.
- Self-assessment [ Time Frame: Baseline, 1 year, 2 years ]Patient's self-assessment questionnaire will be analyzed to find out which parameters are of most importance for the patient.
- EWC [ Time Frame: Baseline ]Edinbourgh wrist calculator will be used to estimate the propability of loss of reduction during the follow-up.
- Frailty [ Time Frame: Baseline ]Clinical Frailty Score
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879656
| Denmark | |
| Viborg Regional Hospital | |
| Viborg, Denmark | |
| Finland | |
| Jyväskylä Central Hospital | |
| Jyväskylä, Finland | |
| Pori Central Hospital | |
| Pori, Finland | |
| Tampere University Hospital | |
| Tampere, Finland, 33820 | |
| Sweden | |
| Karolinska University Hospital | |
| Stockholm, Sweden | |
| Study Director: | Ville Mattila, Prof | Tampere University Hospital | |
| Principal Investigator: | Antti Launonen, MD | Tampere University Hospital | |
| Study Chair: | 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 |
| Responsible Party: | Antti Launonen, MD, PhD, Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT02879656 |
| Other Study ID Numbers: |
R16105 |
| First Posted: | August 26, 2016 Key Record Dates |
| Last Update Posted: | May 14, 2024 |
| Last Verified: | May 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Fractures, Bone Radius Fractures Wrist Fractures Wounds and Injuries |
Forearm Injuries Arm Injuries Wrist Injuries |