Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation

Официальное название

DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation

Обзор

This study is to evaluate whether the dynamic Medial Patellofemoral Ligament (MPFL) reconstruction as described by Becher is a successful operation technique to prevent patella instability and restore quality of life. It is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction

Подробное описание

The recurrent dislocation rate of conservatively treated chronic patellar instability is high, therefore, it is recommended to manage it surgically. A frequently used surgical technique is static medial patellofemoral ligament (MPFL) reconstruction (e.g. Schöttle-technique). A novel dynamic surgical technique according to Becher was developed, addressing the most common complications occurring in static reconstruction, which are malpositioning and overtensioning of the graft. This study is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction.

Вмешательства

• Процедура Static reconstruction technique according to Schöttle
  In static MPFL reconstruction, a graft (harvested autologous gracilis tendon or allogen transplant) is attached to the femoral and patellar bones using tunnels, screws, and/or anchors.
• Процедура Dynamic reconstruction technique according to Becher
  Dynamic MPFL procedure by detaching and reinserting only the distal part of a hamstring muscle to the patella and leaving the proximal tendon attached to its muscle. This way the patella position can be adjusted dynamically by hamstring contraction.

Первичные конечные точки

• Change in Kujala score [Срок оценки: up to 24 months]

Вторичные конечные точки (12)

• Number of recurrent patella dislocation [Срок оценки: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)]
• Number of revision surgery [Срок оценки: From MPFL surgery to occurring revision surgery (up to 24 months)]
• Number of complications (other than revision surgery, e.g. infection, wound healing disorder) [Срок оценки: From MPFL surgery to occurring complication (up to 24 months)]
• Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups [Срок оценки: up to 24 months]
• Change in International Knee Documentation Committee (IKDC)-2000 from preoperative screening, at the hospitalization time and four postoperative follow ups [Срок оценки: up to 24 months]
• Change in EQ-5D-5L from preoperative screening, at the hospitalization time and four postoperative follow ups EQ-5D- EQ-5D-5L [Срок оценки: up to 24 months]
• Change in pain level using the numeric rating scale from preoperative screening, at the hospitalization time and four postoperative follow ups [Срок оценки: up to 24 months]
• Operation time [Срок оценки: During MPFL surgery (up to 1 day)]
• Hospitalization time [Срок оценки: During hospitalization (up to 1 month)]
• Change in gait asymmetry [Срок оценки: Preoperatively and 1 year postoperative]
• Change in isokinetic muscle strength [Срок оценки: Preoperatively and 1 year postoperative]
• Change in timing of muscle activity [Срок оценки: Preoperatively and 1 year postoperative]

Критерии участия

Критерии включения

• Patients treated with isolated dynamic (operation procedure according to Becher et al.using the gracilis tendon) or static MPFL plastic (operation procedure according to Schöttle et al. using the gracilis tendon). MPFL reconstruction will be performed in patients with preceding patella dislocation with: 1) a Patella-Instability-Severity (PIS) score ≤ 3 with concomitant flake fracture or 2) a PIS score ≥ 4 with clinical asymptomatic trochlea dysplasia (patella stability between 30°-60° knee flexion) without other clinically relevant static risk factors.
• Closed growth plates

Критерии исключения

• Combined procedures with trochleoplasty (high grade trochlea dysplasia, type Dejour C,D with clinical instability between 30° and 60° of knee flexion)
• combined procedures with cartilage transplantation
• High grade patellofemoral arthritis (Kellgren Lawrence score ≥3)
• combined procedures with femoral or tibial osteotomy
• Clinically eminent valgus axis (>15° valgus)
• Femoral internal rotation >20°, tibial external rotation >40°
• Instability of the cruciate or collateral ligaments
• Known significant musculoskeletal disease
• Cognitive impairment

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 2 центра

• Department of Orthopaedics and Traumatology, University Hospital Basel — Basel
• Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic — Rheinfelden

Публикации

• Bartsch A, Nuesch C, Rieger B, Mundermann A, Egloff C. Dynamic versus static medial patellofemoral ligament reconstruction technique in the treatment of recurrent patellar dislocation: a randomized clinical trial protocol. J Orthop Surg Res. 2022 Jul 10;17(1):345. doi: 10.1186/s13018-022-03158-6. PMID 35818060

Идентификаторы

NCT: NCT04849130 · 2020-02701; mu21Egloff

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗