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Набор скоро начнётся NCT07209605

Mini-anchor Versus Pull-out Suture for Surgical Management

Без фазы С лечением Volar Plate Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group A Pull-out Suture Technique, Group B- Mini-anchor Technique.
Кому может быть актуально
Состояния в реестре: Volar Plate Injury. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

  • Процедура Group A Pull-out Suture Technique
    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 . .
  • Процедура Group B- Mini-anchor Technique
    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.

Первичные конечные точки

  • range of motion by geniometer [Срок оценки: 6weeks]

Критерии участия

Inclusion Criteria::

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07209605 · Soh-Med-25-9-19MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗