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Distal Radius Fractures in Patients Over 65 Years, Operation or Cast? (DROC)

Primary Purpose

Distal Radius Fracture

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Volar plate
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture

Eligibility Criteria

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

Inclusion Criteria:

  • AO/OTA class A- and C-fractures
  • Age > 65 years
  • Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings:
  • dorsal angulation > 10 degrees
  • radial shortening > 3 mm
  • intraarticular step-off > 2 mm
  • Ability to sign an informed consent
  • Acute fracture, inclusion within 20 days from injury.
  • Ability to reconstruct the articular surface with a volar locking plate

Exclusion Criteria:

  • Volar angulated fractures and AO type B
  • Associated diseases contraindicating surgery
  • Mental impairment, nursery home patient
  • Earlier wrist injury
  • Pathological fractures
  • Open fractures (>Gustilo-Anderson I) or damaged soft tissue
  • Drug abuse
  • Concomitant injuries that might affect outcome
  • Congenital anomaly of affected extremity
  • Median nerve compression that requires acute operation
  • Foreign language
  • Tourists

Sites / Locations

  • Oslo University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Cast immobilization

Operation

Arm Description

Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.

Operation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.

Outcomes

Primary Outcome Measures

Quick disabilities of the arm, shoulder and hand; Quick-DASH
Questionnaire

Secondary Outcome Measures

Quick DASH
Questionnaire
Patient rated wrist evaluation (PRWE)
PRWE, Questionnaire
Grip strength
score
Range of motion
score
Over all satisfaction
Over all satisfaction with hand function, numeric scale 0-10
Complications
Registration of complications
X-ray, wrist
Radial shortening, dorsal tilt, intraarticular step-off
EQ-5d (EuroQol)
Questionnaire
Registration of need for assistance in daily life
Registration of need for assistance in daily life to register costs generated

Full Information

First Posted
January 5, 2015
Last Updated
September 9, 2021
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02336035
Brief Title
Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?
Acronym
DROC
Official Title
Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.
Detailed Description
The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate. The investigators are planning a non-inferiority design. The current study will test the following null hypothesis: In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up. The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cast immobilization
Arm Type
No Intervention
Arm Description
Cast immobilization for 5 weeks from primary injury/reduction. Thereafter active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.
Arm Title
Operation
Arm Type
Experimental
Arm Description
Operation with a volar plate. Cast immobilization for 2 weeks after operation, thereafter active motion without weight for 4 weeks. 6 weeks after operation the patients are allowed active exercise within the range of pain. Both groups will be followed after 3, 6 and 12 months, and after 2 and 5 years.
Intervention Type
Procedure
Intervention Name(s)
Volar plate
Other Intervention Name(s)
Volar locking plate, VLP
Intervention Description
Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate
Primary Outcome Measure Information:
Title
Quick disabilities of the arm, shoulder and hand; Quick-DASH
Description
Questionnaire
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quick DASH
Description
Questionnaire
Time Frame
3 and 6 months; 2 and 5 years
Title
Patient rated wrist evaluation (PRWE)
Description
PRWE, Questionnaire
Time Frame
3, 6 and 12 months; 2 and 5 years
Title
Grip strength
Description
score
Time Frame
3, 6 and 12 months; 2 and 5 years
Title
Range of motion
Description
score
Time Frame
3, 6 and 12 months; 2 and 5 years
Title
Over all satisfaction
Description
Over all satisfaction with hand function, numeric scale 0-10
Time Frame
6 weeks; 3, 6 and 12 months; 2 and 5 years
Title
Complications
Description
Registration of complications
Time Frame
6 weeks; 3, 6 and 12 months; 2 and 5 years
Title
X-ray, wrist
Description
Radial shortening, dorsal tilt, intraarticular step-off
Time Frame
6 weeks; 3 and 12 months; 2 and 5 years
Title
EQ-5d (EuroQol)
Description
Questionnaire
Time Frame
6 weeks; 3, 6 and 12 months; 2 and 5 years
Title
Registration of need for assistance in daily life
Description
Registration of need for assistance in daily life to register costs generated
Time Frame
6 weeks; 3, 6 and 12 months; 2 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AO/OTA class A- and C-fractures Age > 65 years Unacceptable primary reduction or redislocation < 20 days post-injury with at least one of the following findings: dorsal angulation > 10 degrees radial shortening > 3 mm intraarticular step-off > 2 mm Ability to sign an informed consent Acute fracture, inclusion within 20 days from injury. Ability to reconstruct the articular surface with a volar locking plate Exclusion Criteria: Volar angulated fractures and AO type B Associated diseases contraindicating surgery Mental impairment, nursery home patient Earlier wrist injury Pathological fractures Open fractures (>Gustilo-Anderson I) or damaged soft tissue Drug abuse Concomitant injuries that might affect outcome Congenital anomaly of affected extremity Median nerve compression that requires acute operation Foreign language Tourists
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Erik Madsen, Professor
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University hospital
City
Oslo
ZIP/Postal Code
0586
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Distal Radius Fractures in Patients Over 65 Years, Operation or Cast?

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