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

Official title

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

Overview

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

Detailed description

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.

Interventions

• Procedure 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.
• 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.

Primary outcome measures

• Change in Kujala score [Time frame: up to 24 months]

Secondary outcome measures (12)

• Number of recurrent patella dislocation [Time frame: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)]
• Number of revision surgery [Time frame: From MPFL surgery to occurring revision surgery (up to 24 months)]
• Number of complications (other than revision surgery, e.g. infection, wound healing disorder) [Time frame: 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 [Time frame: up to 24 months]
• Change in International Knee Documentation Committee (IKDC)-2000 from preoperative screening, at the hospitalization time and four postoperative follow ups [Time frame: 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 [Time frame: 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 [Time frame: up to 24 months]
• Operation time [Time frame: During MPFL surgery (up to 1 day)]
• Hospitalization time [Time frame: During hospitalization (up to 1 month)]
• Change in gait asymmetry [Time frame: Preoperatively and 1 year postoperative]
• Change in isokinetic muscle strength [Time frame: Preoperatively and 1 year postoperative]
• Change in timing of muscle activity [Time frame: Preoperatively and 1 year postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Switzerland · 2 centers

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

Publications

• 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

Identifiers

NCT: NCT04849130 · 2020-02701; mu21Egloff

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗