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Volar Plate InjuryNCT07209605

Mini-anchor Versus Pull-out Suture for Surgical Management

A study testing Group A Pull-out Suture Technique and Group B- Mini-anchor Technique in people with Volar Plate Injury, run by Sohag University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Volar plate injuries of the joint are among the most common traumatic lesions in the hand. These injuries result from hyperextension trauma, leading to volar plate avulsion, often accompanied by collateral ligament injuries or fractures of the volar plate Conventional repair techniques include pull-out . Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Volar Plate Injury
What is being tested?
Group A Pull-out Suture Technique and Group B- Mini-anchor Technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
1 Oct 2025to 1 Apr 2026
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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 18-55 years.
  • Both sexes.
  • Isolated volar plate injury.
  • Closed injuries.
  • Willingness to participate and follow rehabilitation protocol.

Who cannot join

  • Osteoprotic patients
  • Associated neurovascular or tendon injuries.
  • Open fractures or infections.
  • Previous surgeries on the same finger.
  • Inability to follow up.

About this study

Official title: Mini-anchor Versus Pull-out Suture for Surgical Management of Volar Plate Injuries

Volar plate injuries of the joint are among the most common traumatic lesions in the hand. These injuries result from hyperextension trauma, leading to volar plate avulsion, often accompanied by collateral ligament injuries or fractures of the volar plate Conventional repair techniques include pull-out . Although widely used, pull-out sutures are associated with specific complications such as skin irritation. The external suture may also interfere with early mobilization, a key factor for good postoperative outcomes (3).

Suture anchors have emerged as a modern alternative, offering internal fixation without the need for pull out sutures. Their application is believed to promote faster recovery, minimize soft tissue irritation, and early mobilization

Read the detailed description

Volar plate injuries of the joint are among the most common traumatic lesions in the hand. These injuries result from hyperextension trauma, leading to volar plate avulsion, often accompanied by collateral ligament injuries or fractures of the volar plate Conventional repair techniques include pull-out . Although widely used, pull-out sutures are associated with specific complications such as skin irritation. The external suture may also interfere with early mobilization, a key factor for good postoperative outcomes (3).

Suture anchors have emerged as a modern alternative, offering internal fixation without the need for pull out sutures. Their application is believed to promote faster recovery, minimize soft tissue irritation, and early mobilization Aim of the Work The aim of this study is to compare the clinical and functional outcomes of mini-anchor versus pull-out suture techniques in surgical management of volar plate injuries of the PIP joint.

-Place of the study: Sohag University Hospitals after approval from the institutional ethical committee.

-Type of the study: A prospective randomized clinical trial.

  • Study period:

From 1/10/2025 to 1/4/2026……………

  • Patients:

This study will be conducted on patients with volar plate injuries of the PIP joint. An online randomization program (http://www.randomizer.org) will be used to generate a random list and each patients' code will be kept in an opaque sealed envelope. Patients will be randomly allocated with 1:1 allocation ratio into two groups in a parallel manner:

  • Group A: Patients will be managed using the modified pull-out suture technique.
  • Group B: Patients will undergo repair using mini suture anchors.
  • Inclusion Criteria:
  • Patients aged 18-55 years.
  • Both sexes.
  • Isolated volar plate injury.
  • Closed injuries.
  • Injury duration < 7 days.
  • Willingness to participate and follow rehabilitation protocol.
  • Exclusion Criteria:
  • Osteoprotic patients
  • Associated neurovascular or tendon injuries.
  • Open fractures or infections.
  • Previous surgeries on the same finger.
  • Inability to follow up.
Being tested
Group A Pull-out Suture Technique, Group B- Mini-anchor Technique
Keywords
Mini-anchor versus Pull-out Suture for Surgical Management of Volar Plate Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A Pull-out Suture TechniqueProcedure or surgery

    A Brunner volar incision will be made, and the volar plate avulsion fragment will be identified. A 2-0 nonabsorbable braided suture will be passed through the volar plate using Kessler pattern, and Keith needles will be used to exit the sutures dorsally . .

  • Group B- Mini-anchor TechniqueProcedure or surgery

    Using the same volar approach, the volar plate will be reattached with two Mitek Micro QuickAnchors (1.3 x 3.7 mm), placed at the distal phalanx. Anchors will be inserted under fluoroscopic guidance to avoid dorsal cortex penetration. A hemimodified Kessler stitch pattern will be used with 3-0 polyester sutures.

Study groups in NCT07209605
Study groupRoleWhat they receive
Group A - Pull-out Suture TechniqueActive comparatorNot described
Receives: Procedure: Group A Pull-out Suture Technique
Group B - Mini-anchor TechniqueActive comparatorUsing the same volar approach, the volar plate will be reattached with two Mitek Micro QuickAnchors (1.3 x 3.7 mm), placed at the distal phalanx. Anchors will be inserted under fluoroscopic guidance to avoid dorsal cortex penetration. A hemimodified Kessler stitch pattern will be used with 3-0 polyester sutures.
Receives: Procedure: Group B- Mini-anchor Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. range of motion by geniometer

    Measured: 6weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07209605
Sponsor's protocol ID
Soh-Med-25-9-19MS
Status last verified
Sep 2025
First submitted
29 Sep 2025
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Group A Pull-out Suture Technique and Group B- Mini-anchor Technique in people with Volar Plate Injury, run by Sohag University.

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 5 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

range of motion by geniometer (time frame: 6weeks). 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 7 Oct 2025.

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