Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilisation Following Closed Reduction.

NCT05012345 | Unknown DMC

• 1 other identifier: ECM 3 (vvv) 09/02/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A single-blinded randomized controlled trial is initiated. Four weeks of plaster cast immobilization is compared with six weeks of plaster cast immobilization in adult patients with adequately reduced distal radius fracture. Primary outcome parameters are functional outcomes measured with the Patient Rated Wrist Evaluation after 6 months of follow-up (FU). Secondary outcomes are Disability of Arm, Shoulder and Hand Score after 6 months and one year, 36-Item Short-Form Health Survey after 6 months and one year, functional outcome earlier in Follow up (6 weeks, 12 weeks, 6 months, and one year), range of motion, pain level, and complications: number of re-interventions, secondary displacement, delayed and non-union.

Conditions

Distal Radius Fracture

Keywords

distal radius fracture, 4 weeks, 6 weeks.

Outcome Measures

Primary Outcomes (6)

• Patient Rated Wrist Evaluation (PRWE)

  is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living

  One year

• Patient Rated Wrist Evaluation (PRWE)

  is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living

  Three months

• Patient Rated Wrist Evaluation (PRWE)

  is a 15-item questionnaire designed to measure wrist pain and disability in activities of daily living

  Six months

• Quick Disability of Arm and Shoulder (DASH)

  is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties

  3 months

• Quick Disability of Arm and Shoulder (DASH)

  is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties

  6 months

• Quick Disability of Arm and Shoulder (DASH)

  is a self-report questionnaire that assesses a person's perceived level of incapacity pertaining to disability of the arm, shoulder, and hand and is based on the 30-item DASH instrument, where each item on the QuickDASH was retained relative to key concepts of upper-limb functioning as well as the selection of the highest ranked items from the original according to their psychometric properties

  One year

Secondary Outcomes (4)

• Range of Movement

  3 months

• Range of Movement

  6 months

• Range of Movement

  one year

• Complications

  one year

Study Arms (2)

4 Weeks cast immobilisation

EXPERIMENTAL

Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 4 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.

Procedure: Below Elbow cast

6 Weeks cast immobilisation

EXPERIMENTAL

Patients with fracture distal radius ( indicated for conservative treatment) will stay in a below-elbow cast for 6 weeks. Following immobilisation, treatment will be the same for both groups, in which additional physiotherapy after removal of the cast is advised and exercises to train wrist function will be given. As extra structured advice programmes may cause no extra benefit for the patient, this was not generally prescribed. However, during FU visits, patients will be asked if they were treated by a physiotherapist. If this is the case, details on the number of sessions per week and the total number of weeks the patient received physiotherapy, will be collected.

Procedure: Below Elbow cast

Interventions

Below Elbow cast PROCEDURE

below-elbow cast ( 4 or 6 weeks )

4 Weeks cast immobilisation; 6 Weeks cast immobilisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary displaced distal radius fracture
• age older than 18 years.
• Adequate closed reduction of the distal radius fracture according to Lidström criteria for misalignment.

You may not qualify if:

• Ipsilateral fractures proximal to the distal radius.
• Pre-existent abnormalities or functional deficits of the fractured wrist that influences the patient reported function of the wrist.
• Open fractures.

Sponsors & Collaborators

• Cork University Hospital: lead

Study Sites (1)

Cork University Hospital

Cork, T12DFK4, Ireland

Location

Related Publications (1)

• Elbardesy H, Yousaf MI, Reidy D, Ansari MI, Harty J. Distal radial fractures in adults: 4 versus 6 weeks of cast immobilisation after closed reduction, a randomised controlled trial. Eur J Orthop Surg Traumatol. 2023 Dec;33(8):3469-3474. doi: 10.1007/s00590-023-03574-2. Epub 2023 May 16.

  PMID: 37191887 DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Central Study Contacts

James Harty, Professor

CONTACT

00353214921383; jamesharty@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective single-blinded randomised clinical trial

Study Record Dates

• First Submitted: July 24, 2021
• First Posted: August 19, 2021
• Study Start: August 20, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: July 2022

Locations

IE (1)