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

Primary Purpose

Colles' Fracture, Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Flexion-ulnar cast
Functional cast
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colles' Fracture focused on measuring wrist fracture, colles fracture, non-operative, rehabilitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Finland Central Hospital
  • Satakunta Central Hospital
  • Tampere Univeristy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm 1

Arm 2

Arm Description

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 22, 2016
Last Updated
May 18, 2018
Sponsor
Tampere University Hospital
Collaborators
Central Finland Hospital District, Satakunta Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02894983
Brief Title
Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Central Finland Hospital District, Satakunta Central Hospital

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colles' Fracture, Distal Radius Fracture
Keywords
wrist fracture, colles fracture, non-operative, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Arm Description
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Arm Title
Arm 2
Arm Type
Other
Arm Description
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Intervention Type
Other
Intervention Name(s)
Flexion-ulnar cast
Other Intervention Name(s)
Conservative treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Functional cast
Other Intervention Name(s)
Conservative treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Description
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.
Time Frame
2 years
Title
Quality of life measured with the 15-D.
Description
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.
Time Frame
2 years
Title
Pain measured in Visual Analogue Scale (VAS).
Description
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.
Time Frame
Baseline, 3 months, 1 year, 2 years
Title
Range of motion (ROM) is measured with a goniometer
Description
The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.
Time Frame
3 months
Title
Grip strength is measured with a dynamometer
Description
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.
Time Frame
3 months
Title
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Mattila, MD, Professor
Organizational Affiliation
Tampere Univeristy Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antti Launonen, MD, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Teemu Hevonkorpi, MBBS
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lauri Raittio, MBBS
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Toni Luokkala, MD
Organizational Affiliation
Central Finland Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, MD, PhD
Organizational Affiliation
Central Finland Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juha Kukkonen, MD, PhD
Organizational Affiliation
Satakunta Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Minna Laitinen, Adjacent prof
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
Satakunta Central Hospital
City
Pori
Country
Finland
Facility Name
Tampere Univeristy Hospital
City
Tampere
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32469881
Citation
Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.
Results Reference
derived
PubMed Identifier
28923035
Citation
Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. 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 study protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.
Results Reference
derived

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

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