Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization

Distal Radial Fractures in Adult Patients: 4 Weeks Versus 6 Weeks of Cast Immobilization-A Randomized Controlled Trial

Post-intervention outcomes comparing casting in distal radius fractures of four weeks versus six weeks.

Study Overview

• Status: Enrolling by invitation
• Conditions: Fracture Forearm; Radius Distal Fracture
• Intervention / Treatment: Procedure: Short Arm Cast for Distal Radius Fracture for four weeks; Procedure: Short Arm Cast for Distal Radius Fracture for six weeks

Detailed Description

Cast immobilization for 6 weeks remains the mainstay of therapy for distal radius fractures. To challenge the therapeutic time frame, participants will be randomized into two arms, and the treatment arm will undergo immobilization for 4 weeks. Outcomes will be assessed at cast removal and then at 3 and 6 months prospectively using the Quick-DASH score and the DASH score (only at 6 months).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Liaquat National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with DRF undergoing conservative management with cast immobilization
• Age between 18 to 50 years.

Exclusion Criteria:

• Any syndromic patients
• Any patients with musculoskeletal disease
• Patients having osteoporosis
• Post-menopausal females
• Smokers
• Ages less than 18 or greater than 50
• Patients presenting with intra-articular fractures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cast immobilization for four weeks; Scotch cast immobilization for a period of four weeks applied to distal radius fractures.	Procedure: Short Arm Cast for Distal Radius Fracture for four weeks; Scotch cast immobilization below elbow for four weeks; Other Names: Cast; Splint
Active Comparator: Cast immobilization for six weeks; Scotch cast immobilization for a period of six weeks applied to distal radius fractures	Procedure: Short Arm Cast for Distal Radius Fracture for six weeks; Scotch cast immobilization below elbow for six weeks; Other Names: Cast; Splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Disability of Arm, Shoulder, and Hand Score (Quick DASH)	Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.	Four weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)	Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.	Six weeks (Cast Removal)
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)	Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.	3 months after cast removal
Quick Disability of Arm, Shoulder, and Hand (Quick DASH)	Quick Disability of Arm, Shoulder, and Hand (Quick DASH) score is calculated using a formula based on responses to an 11-item questionnaire. Scores range from 0 to 100, where 0 indicates no disability and 100 indicates the most severe disability.	6 months after cast removal
Disability of Arm, Shoulder, and Hand Score	The Disability of Arm, Shoulder, and Hand Score (DASH) is a 30-item questionnaire with scores ranging from 1 to 5 for each item. The final scores are formulated from 0 to 100, where a higher score indicates greater disability and a lower score indicates little to no disability.	6 months post-removal of cast immobilizations

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Deviation	Radial deviation ranges from 15-25°. More deviation suggests more joint movement and is associated with better outcomes.	6 months post-cast immobilization removal
Ulnar Deviation	Ulnar deviation ranges from 30-45 °. More deviation suggests more joint movement and is associated with better outcomes.	6 months post-cast immobilization removal.
Dorsiflexion	Dorsiflexion ranges from 8-26 °. More flexion suggests more joint movement and is associated with better outcomes.	6 months post-cast immobilization removal.
Palmar Flexion	Palmar flexion ranges from 70-90 °. More flexion suggests more joint movement and is associated with better outcomes.	6 months post-cast immobilization removal.

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College
• Investigators: Principal Investigator: Mohammad Nabeel Aamir Syed, MBBS, MD

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Estimated): November 18, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Arm Injuries; Wrist Injuries; Wrist Fractures; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Splints; POLR1G protein, human
• Other Study ID Numbers: R.C-LNH-Orthpedics-05/2025/52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No