Proximal Interphalangeal Joint FractureNCT07714356
Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.
A study testing Suzuki Frame and Standard Conventional Treatment. in people with Proximal Interphalangeal Joint Fracture, run by Yehia Mohamed at 1 site in Egypt.
Trial summary
This prospective randomized controlled trial aims to evaluate the functional and radiological outcomes of using the Suzuki frame for treating comminuted intra-articular fractures of the proximal interphalangeal (PIP) joint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Interphalangeal Joint Fracture
- What is being tested?
- Suzuki Frame and Standard Conventional Treatment.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Either sex.
- Simple or compound (open) fractures.
- Isolated fracture involving a single finger.
- Comminuted intra-articular proximal interphalangeal (PIP) joint fractures.
Who cannot join
- Age <18 years.
- Fractures involving the thumb.
- Fractures involving the toes.
- Near-total finger amputations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University Hospitals
Sohag
Yahia Mohamed Esmail, +20 12 20709009, yehia_mohamed_post@med.sohag.edu.eg
About this study
This prospective randomized controlled trial aims to evaluate the functional and radiological outcomes of using the Suzuki frame for treating comminuted intra-articular fractures of the proximal interphalangeal (PIP) joint. The study involves adult patients with PIP joint fractures who will be treated using dynamic joint distraction (ligamentotaxis) via the Suzuki frame. The primary goal is to assess whether this technique facilitates early active finger motion, reduces joint stiffness, and improves long-term functional recovery compared to other methods.
Read the detailed description
Fractures involving the proximal interphalangeal (PIP) joint are challenging to manage, often leading to pain, stiffness, and functional impairment. Dynamic joint distraction using ligamentotaxis has emerged as an alternative to open surgery to facilitate early mobilization while avoiding the risks of soft-tissue dissection.
In this study, we are investigating the short-term functional and radiological outcomes of the Suzuki frame, which utilizes a 1.2-mm Kirschner wire axial traction pin and a hook pin connected by rubber bands to maintain joint congruency. Participants will include adults with isolated, comminuted intra-articular PIP joint fractures. Patients will be monitored over a 6-month follow-up period.
Clinical evaluation will include the Visual Analogue Scale (VAS) for pain and the QuickDASH score for functional disability. Radiological assessment will focus on joint alignment and reduction. The study will be conducted at Sohag University Hospital, following an intention-to-treat analysis principle.
- Conditions
- Proximal Interphalangeal Joint Fracture
- Being tested
- Suzuki Frame, Standard Conventional Treatment.
- Keywords
- Suzuki Frame, Comminuted Fracture, Ligamentotaxis, Dynamic Joint Distraction, Finger Fracture
- Medical subject headings
- Fractures, Comminuted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suzuki FrameDevice
Dynamic joint distraction using a 1.2-mm axial traction K-wire in the proximal phalanx, a 1.2-mm hook K-wire in the middle phalanx, and rubber bands to maintain joint congruency and facilitate early motion.
Standard Conventional Treatment.Procedure or surgery
"tandard conventional management of comminuted intra-articular proximal interphalangeal joint fractures according to institutional protocols, including closed reduction and splinting or open reduction internal fixation as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Suzuki Frame Fixation Group | Experimental | Patients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated with dynamic joint distraction using the Suzuki frame (1.2-mm Kirschner wires and rubber bands). Receives: Device: Suzuki Frame |
| Standard Conventional Treatment Group | Active comparator | Patients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated using standard conventional management as per hospital protocol (e.g., closed reduction and splinting or internal fixation). Receives: Procedure: Standard Conventional Treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome using the QuickDASH score.
The QuickDASH score is a standardized tool used to measure upper limb functional ability. Higher scores indicate greater disability (range 0-100).
Measured: 6 months post-operatively
Secondary outcomes (2)
Pain assessment using the Visual Analogue Scale (VAS)
Pain level assessed on a scale from 0 (no pain) to 10 (worst possible pain).
Measured: 6 months post-operatively
Range of Motion (ROM) of the PIP joint.
Range of motion (ROM) expressed as the flexion-extension arc in degrees.
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Interphalangeal Joint FractureStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yehia Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yehia Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714356
- Sponsor's protocol ID
- Soh-Med-26-3-15MS
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Suzuki Frame Fixation in Comminuted Fractures of the Proximal Interphalangeal Joint.
- ClinicalTrials.gov ID
- NCT07714356
- Acronym / sponsor ID
- Soh-Med-26-3-15MS
- Conditions
- Proximal Interphalangeal Joint Fracture
- Keywords
- Suzuki Frame, Comminuted Fracture, Ligamentotaxis, Dynamic Joint Distraction, Finger Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Yehia MohamedUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 20 Jul 2026 (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.
This prospective randomized controlled trial aims to evaluate the functional and radiological outcomes of using the Suzuki frame for treating comminuted intra-articular fractures of the proximal interphalangeal (PIP) joint. The study involves adult patients with PIP joint fractures who will be treated using dynamic joint distraction (ligamentotaxis) via the Suzuki frame. The primary goal is to assess whether this technique facilitates early active finger motion, reduces joint stiffness, and improves long-term functional recovery compared to other methods.
Detailed description
Fractures involving the proximal interphalangeal (PIP) joint are challenging to manage, often leading to pain, stiffness, and functional impairment. Dynamic joint distraction using ligamentotaxis has emerged as an alternative to open surgery to facilitate early mobilization while avoiding the risks of soft-tissue dissection.
In this study, we are investigating the short-term functional and radiological outcomes of the Suzuki frame, which utilizes a 1.2-mm Kirschner wire axial traction pin and a hook pin connected by rubber bands to maintain joint congruency. Participants will include adults with isolated, comminuted intra-articular PIP joint fractures. Patients will be monitored over a 6-month follow-up period.
Clinical evaluation will include the Visual Analogue Scale (VAS) for pain and the QuickDASH score for functional disability. Radiological assessment will focus on joint alignment and reduction. The study will be conducted at Sohag University Hospital, following an intention-to-treat analysis principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suzuki Frame Fixation Group | Experimental | Device: Suzuki FramePatients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated with dynamic joint distraction using the Suzuki frame (1.2-mm Kirschner wires and rubber bands). |
| Standard Conventional Treatment Group | Active comparator | Procedure: Standard Conventional Treatment.Patients with comminuted intra-articular proximal interphalangeal (PIP) joint fractures treated using standard conventional management as per hospital protocol (e.g., closed reduction and splinting or internal fixation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Either sex.
- Simple or compound (open) fractures.
- Isolated fracture involving a single finger.
- Comminuted intra-articular proximal interphalangeal (PIP) joint fractures.
Key exclusion criteria (4 listed)
- Age <18 years.
- Fractures involving the thumb.
- Fractures involving the toes.
- Near-total finger amputations.
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 |
|---|---|---|
| Suzuki FrameDynamic joint distraction using a 1.2-mm axial traction K-wire in the proximal phalanx, a 1.2-mm hook K-wire in the middle phalanx, and rubber bands to maintain joint congruency and facilitate early motion. | Device | Suzuki Frame Fixation Group |
| Standard Conventional Treatment."tandard conventional management of comminuted intra-articular proximal interphalangeal joint fractures according to institutional protocols, including closed reduction and splinting or open reduction internal fixation as indicated. | Procedure or surgery | Standard Conventional Treatment Group |
Primary outcome
Functional Outcome using the QuickDASH score.
Time frame: 6 months post-operatively
The QuickDASH score is a standardized tool used to measure upper limb functional ability. Higher scores indicate greater disability (range 0-100).
2 secondary outcomes
Pain assessment using the Visual Analogue Scale (VAS)
Time frame: 6 months post-operatively
Range of Motion (ROM) of the PIP joint.
Time frame: 6 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suzuki Frame and Standard Conventional Treatment. in people with Proximal Interphalangeal Joint Fracture, run by Yehia Mohamed at 1 site in Egypt.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 20 Jul 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahia Mohamed Esmail, MSc (+20 12 20709009, yehia_mohamed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome using the QuickDASH score. (time frame: 6 months post-operatively). 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 20 Jul 2026.