NCT07576075

Brief Summary

Local data has shown conflicting results regarding the outcomes of volar locking plates versus external fixators in distal intra-articular radius fractures. Therefore, the current study was planned with the objective of comparing the outcome of a volar locking plate versus an external fixator in distal intra-articular radius fractures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress81%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 5, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Articular Fracture

Outcome Measures

Primary Outcomes (3)

  • Operative time

    Operative time will be measured in minutes from skin incision to skin closure.

    2 hours

  • Blood Loss

    Blood loss will be estimated in milliliters, measuring clots in a suction bottle, the difference between the pre- and postoperative sponge weights using the 1 g-1 ml formula, and blood clots in a clenched fist.

    3 hours

  • Wrist function

    Wrist function will be evaluated using the Mayo Wrist Score. Patient frequencies will be recorded, with scores of 90-100 points reflecting an excellent outcome, 80-89 points indicating a good outcome, 60-79 points representing a satisfactory outcome, and scores below 60 points denoting a poor outcome.

    3 months

Study Arms (2)

Group-A

EXPERIMENTAL

Patients will be treated with volar locking plates. The distal radius fragments will be stabilized using the conventional modified Henry's volar technique with 2.4 mm locking compression plates.

Procedure: Volar locking plates

Group-B

EXPERIMENTAL

Patients will be employed with an external fixator, directly fixing to the second or third metacarpal bone using 3-mm pins and the radius using 4-mm Schanz pins.

Procedure: External Fixator

Interventions

Volar locking platesPROCEDURE

Patients will be treated with volar locking plates. The distal radius fragments will be stabilized using the conventional modified Henry's volar technique with 2.4 mm locking compression plates.

Group-A
External FixatorPROCEDURE

Patients will be employed with an external fixator, directly fixing to the second or third metacarpal bone using 3-mm pins and the radius using 4-mm Schanz pins.

Group-B

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Any gender
  • Aged 20 to 60
  • with intra-articular fractures of the distal radius
  • The fracture lasted less than seven days

You may not qualify if:

  • Patients with bilateral distal radius fractures and any further related injuries or fractures
  • Distal radius open fractures
  • Individuals receiving immunosuppressive, chemotherapeutic, or corticosteroid medications (based on medical history and records)
  • Individuals with underlying medical co-morbidities, such as diabetes and uncontrolled hypertension, (determined by their medical history and record)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

MeSH Terms

Conditions

Intra-Articular Fractures

Interventions

External Fixators

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentEquipment and SuppliesSurgical Fixation Devices

Study Officials

  • Burhan Ulhaq

    Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur

    PRINCIPAL INVESTIGATOR

  • Abdul-Munaf Saud, FCPS

    Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur

    STUDY DIRECTOR

Central Study Contacts

Burhan Ulhaq

CONTACT

+923326456246burhankhan224@gmail.com

Abdul-Munaf Saud, FCPS

CONTACT

+923005111668drabdulmunafsaud@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start

October 5, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations

PA(1)