Comparison of Antegrade and Retrograde Fixation With Intramedullary Screws in Metacarpal Fractures

NCT06920823 | Completed DMC

• 1 other identifier: 111990
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Intramedullary fixation has proven to be an efficacious intervention for metacarpal fractures. Advantages involve stable fixation facilitating early surgical rehabilitation and higher fracture union rates, without increased morbidity. We aimed to compare the results of fixation of metacarpal fractures with headless cannulated screws towards antegrade or retrograde on pain, function and quality of life in patients with metacarpal fractures. Methods: Patients admitted to Pamukkale University Orthopedics and Traumatology Department, due to metacarpal fracture were prospectively included in the study and randomly grouped. A total of 22 patients and 26 metacarpal fractures were assessed. Group I patients were operated with antegrade(proximal entry) , and group II with retrograde (distal entry) , using intramedullary headless cannulated screws. Appropriate screw selection was made by measuring the metacarpal isthmus diameter of the patient's x-ray results (AP and oblique direction). We used headless cannulated screws with diameters between 3.5mm and 5mm in the fractures.

Conditions

Metacarpal Fracture

Keywords

Metacarpal Fracture, Intramedullary Fixation

Outcome Measures

Primary Outcomes (1)

• Radiographic Examination (anteroposterior and oblique diameter)

  Primary bone healing was accepted as union when callus tissue developed in at least 3 cortices on AP and oblique radiographs taken with a radiography device or on the 6th week control radiograph. Radiological measurements were performed by a single observer.

  postop 6th week

Secondary Outcomes (3)

• Range of motion

  postop 6th and 12th week

• Grip strength

  postop 12th week

• Hand functionality (Michigan Hand Outcomes Questionnaire)

  postop 12th week

Study Arms (2)

Group 1

ACTIVE COMPARATOR

antegrade (proximal entry) fixation

Procedure: antegrade (proximal entry) fixation

Group 2

ACTIVE COMPARATOR

retrograde (distal entry) fixation

Procedure: retrograde (distal entry) fixation

Interventions

antegrade (proximal entry) fixation PROCEDURE

In the antegrade headless cannulated screw fixation technique, a small incision was made on the extensor aspect of the fractured metacarpal at the level of the carpometacarpal joint.

Group 1

retrograde (distal entry) fixation PROCEDURE

In the fixation technique with retrograde headless cannulated screw, a small incision was made on the extensor side of the fractured metacarpal at the level of the metacarpophalangeal joint.

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Operated for metacarpal fracture,
• Speak and understand Turkish,
• Understand the verbal and written information given.
• Regular follow-up visits

You may not qualify if:

• Open epiphysis
• Pathological fractures
• Fractures requiring bone grafting

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Study Officials

• Umut Eraslan, PhD

  Faculty of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 10, 2025
• Study Start: October 4, 2021
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)