Metacarpal FractureNCT06920823
Comparison of Antegrade and Retrograde Fixation With Intramedullary Screws in Metacarpal Fractures
A study testing antegrade (proximal entry) fixation and retrograde (distal entry) fixation in people with Metacarpal Fracture, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metacarpal Fracture
- What is being tested?
- antegrade (proximal entry) fixation and retrograde (distal entry) fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Oct 2021to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operated for metacarpal fracture,
- Speak and understand Turkish,
- Understand the verbal and written information given.
- Regular follow-up visits
Who cannot join
- Open epiphysis
- Pathological fractures
- Fractures requiring bone grafting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Antegrade and Retrograde Fixation With Intramedullary Headless Canulated Screws in Patients With 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.
Read the detailed description
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.
- Conditions
- Metacarpal Fracture
- Being tested
- antegrade (proximal entry) fixation, retrograde (distal entry) fixation
- Keywords
- Metacarpal Fracture, Intramedullary Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antegrade (proximal entry) fixationProcedure or surgery
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) fixationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | antegrade (proximal entry) fixation Receives: Procedure: antegrade (proximal entry) fixation |
| Group 2 | Active comparator | retrograde (distal entry) fixation Receives: Procedure: retrograde (distal entry) fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postop 6th week
Secondary outcomes (3)
Range of motion
Range of motion was measured with a universal goniometer. All measurements were made with the patient in the sitting position.
Measured: postop 6th and 12th week
Grip strength
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.
Measured: postop 12th week
Hand functionality (Michigan Hand Outcomes Questionnaire)
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.
Measured: postop 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start4 Oct 2021
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metacarpal FractureStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
- Investigators
- Umut Eraslan, PhD, Principal investigator, Faculty of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920823
- Sponsor's protocol ID
- 111990
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antegrade and Retrograde Fixation With Intramedullary Headless Canulated Screws in Patients With Metacarpal Fractures
- ClinicalTrials.gov ID
- NCT06920823
- Acronym / sponsor ID
- 111990
- Conditions
- Metacarpal Fracture
- Keywords
- Metacarpal Fracture, Intramedullary Fixation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: antegrade (proximal entry) fixationantegrade (proximal entry) fixation |
| Group 2 | Active comparator | Procedure: retrograde (distal entry) fixationretrograde (distal entry) fixation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Operated for metacarpal fracture,
- Speak and understand Turkish,
- Understand the verbal and written information given.
- Regular follow-up visits
Key exclusion criteria (3 listed)
- Open epiphysis
- Pathological fractures
- Fractures requiring bone grafting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antegrade (proximal entry) fixationIn 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. | Procedure or surgery | Group 1 |
| retrograde (distal entry) fixationIn 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. | Procedure or surgery | Group 2 |
Primary outcome
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.
3 secondary outcomes
Range of motion
Time frame: postop 6th and 12th week
Grip strength
Time frame: postop 12th week
Hand functionality (Michigan Hand Outcomes Questionnaire)
Time frame: postop 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umut Eraslan, PhD principal investigator
Faculty of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antegrade (proximal entry) fixation and retrograde (distal entry) fixation in people with Metacarpal Fracture, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Examination (anteroposterior and oblique diameter) (time frame: postop 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.