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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2027-03-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Patellar Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicentre prospective longitudinal randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study assessments blinded by separating the clinicians performing the surgery and independent blind observers assessing the study data. Patients will be blinded to the surgery procedure.

Study Groups

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Static reconstruction technique according to Schöttle

Group Type ACTIVE_COMPARATOR

Static reconstruction technique according to Schöttle

Intervention Type PROCEDURE

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.

Dynamic reconstruction technique according to Becher

Group Type ACTIVE_COMPARATOR

Dynamic reconstruction technique according to Becher

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No