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Completed

NCT Number: NCT06920823

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

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.

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Key information

Conditions

Metacarpal Fracture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

About this study

This was a prospective randomised comparative single-blinded study comparing the effects of intramedullary fixation direction and entry site in patients with metacarpal fractures.

The participants were first evaluated at post-operative 6th week and the last evaluation was performed at post-operative 12th week The evaluations included radiographic union, grip strength measurement (with Jamar hydraulic hand dynamometer), range of motion measurement (compared to the opposite hand), and Michigan Hand Outcome Questionnaire (MHQ) questionnaire. All assessments were performed by the same investigator. The researcher who performed the evaluations did not know which group the participants were in.

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 (CMC) joint and the extensor tendon was excised. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, 1 headless cannulated screw was applied distally.(figure 1) 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 MCP joint, and the extensor tendon split was passed. After fracture reduction, k-wire was inserted intramedullarly. After appropriate drilling, headless cannulated screw was applied proximally.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Open epiphysis
  • Pathological fractures
  • Fractures requiring bone grafting

Treatment and study plan

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.

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.

Primary outcomes

  1. Radiographic Examination (anteroposterior and oblique diameter)

    Time frame: postop 6th week

    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.

Secondary outcomes

  1. Range of motion

    Time frame: postop 6th and 12th week

    Range of motion was measured with a universal goniometer. All measurements were made with the patient in the sitting position.

  2. Grip strength

    Time frame: postop 12th week

    Grip strength was assessed as gross grip and pinch grip with a Jamar hand dynamometer and a pinchmeter according to the recommendation by the American Society of Hand Therapists.

  3. Hand functionality (Michigan Hand Outcomes Questionnaire)

    Time frame: postop 12th week

    Michigan Hand Outcomes Questionnaire consists of a total of 63 items for both hands and each item is scored between 1-5. It evaluates the hand and wrist in 6 domains: overall hand function, activities of daily living, pain, work performance, aesthetics, and patient satisfaction.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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