Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

Distal Radius Fracture Clinical Trial

Official title:

Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894983
• Other study ID #: R16035
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER

• Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria:

• Operative treatment

• 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, forearm or elbow

Related Conditions & MeSH terms

• Colles' Fracture
• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

Other:
• Flexion-ulnar cast
The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.
• Functional cast
The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Locations

Country	Name	City	State
Finland	Central Finland Central Hospital	Jyväskylä
Finland	Satakunta Central Hospital	Pori
Finland	Tampere Univeristy Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Central Finland Hospital District, Satakunta Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Rated Wrist Evaluation (PRWE) measure 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.	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.	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.	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.	Baseline, 3 months, 1 year, 2 years
Secondary	Range of motion (ROM) is measured with a goniometer	The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.	3 months
Secondary	Grip strength is 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
Secondary	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.	2 years