Clinical trial NCT04849130: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patellar Instability
Keywords: chronic patellar instability
static medial patellofemoral ligament (MPFL) reconstruction
static reconstruction technique according to Schöttle
dynamic medial patellofemoral ligament (MPFL) reconstruction
patellofemoral ligament reconstruction
patella dislocation
Patella-Instability-Severity (PIS) score
dynamic reconstruction technique according to Becher
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicentre prospective longitudinal randomized clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Change in Kujala score
timeFrame: up to 24 months
Secondary outcomes:
measure: Number of recurrent patella dislocation
timeFrame: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
measure: Number of revision surgery
timeFrame: From MPFL surgery to occurring revision surgery (up to 24 months)
measure: Number of complications (other than revision surgery, e.g. infection, wound healing disorder)
timeFrame: From MPFL surgery to occurring complication (up to 24 months)
measure: Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups
timeFrame: up to 24 months
measure: Change in International Knee Documentation Committee (IKDC)-2000 from preoperative screening, at the hospitalization time and four postoperative follow ups
timeFrame: up to 24 months
measure: Change in EQ-5D-5L from preoperative screening, at the hospitalization time and four postoperative follow ups EQ-5D- EQ-5D-5L
timeFrame: up to 24 months
measure: Change in pain level using the numeric rating scale from preoperative screening, at the hospitalization time and four postoperative follow ups
timeFrame: up to 24 months
measure: Operation time
timeFrame: During MPFL surgery (up to 1 day)
measure: Hospitalization time
timeFrame: During hospitalization (up to 1 month)
measure: Change in gait asymmetry
timeFrame: Preoperatively and 1 year postoperative
measure: Change in isokinetic muscle strength
timeFrame: Preoperatively and 1 year postoperative
measure: Change in timing of muscle activity
timeFrame: Preoperatively and 1 year postoperative
measure: Change in single legged drop test
timeFrame: Preoperatively and 1 year postoperative
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Traumatology, University Hospital Basel
city: Rheinfelden
country: Switzerland
facility: Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic
Study officials:
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
name: Christian Egloff, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.