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

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879656
• Other study ID #: R16105
• Status: Completed
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: June 6, 2023

Study information

• Verified date: May 2024
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: June 6, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures
• Wrist Fractures

Intervention

Procedure:
• non-operative treatment
conservative treatment with 5 weeks cast immobilization
• operative treatment
surgery with volar locking plate with modified Henry's volar approach

Locations

Country	Name	City	State
Denmark	Viborg Regional Hospital	Viborg
Finland	Jyväskylä Central Hospital	Jyväskylä
Finland	Pori Central Hospital	Pori
Finland	Tampere University Hospital	Tampere
Sweden	Karolinska University Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Hospital District, Regionshospitalet Viborg, Skive, Satakunta Central Hospital

Countries where clinical trial is conducted

Denmark,  Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months, 1 year, 2 years
Secondary	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.	Baseline, 3 months, 1 year, 2 years
Secondary	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.	3 months, 1 year, 2 years
Secondary	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.	3 months, 1 year
Secondary	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.	baseline, 3 months, 1 year, 2 years
Secondary	Physical activity measured with Axivity accelerometer	Physical activity will be measured in a subgroup of patients in two separate follow-up time points.	3 months, 1 year
Secondary	Self-assessment	Patient's self-assessment questionnaire will be analyzed to find out which parameters are of most importance for the patient.	Baseline, 1 year, 2 years
Secondary	EWC	Edinbourgh wrist calculator will be used to estimate the propability of loss of reduction during the follow-up.	Baseline
Secondary	Frailty	Clinical Frailty Score	Baseline