NCT07234370

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 24, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

November 14, 2025

Last Update Submit

November 19, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Radial Deviation

    6 months post-cast immobilization removal

  • Ulnar Deviation

    6 months post-cast immobilization removal.

  • Dorsiflexion

    6 months post-cast immobilization removal.

  • Palmar Flexion

    6 months post-cast immobilization removal.

Study Arms (2)

Cast immobilization for four weeks

EXPERIMENTAL

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

Cast immobilization for six weeks

ACTIVE COMPARATOR

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

Interventions

Scotch cast immobilization below elbow for four weeks

Also known as: Splint, Cast
Cast immobilization for four weeks

Scotch cast immobilization below elbow for six weeks

Also known as: Splint, Cast
Cast immobilization for six weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Wrist Fractures

Interventions

SplintsPOLR1G protein, human

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

External FixatorsOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Mohammad Nabeel Aamir Syed, MBBS, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 18, 2025

Study Start

September 15, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

November 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations