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

NCT04849130 | Recruiting

• 1 other identifier: 2020-02701; mu21Egloff
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

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

Outcome Measures

Primary Outcomes (1)

• Change in Kujala score

  Patient reported knee function and anterior knee pain as assessed with the Kujala score at preoperative screening, at the hospitalization time and four postoperative follow ups . The Kujala scale consists of 13 questions covering a range of physical symptoms and limitations that are presented in a multiple choice answer format, with a different point value assigned to each answer. The maximum score is 100, with higher scores indicating better function.

  up to 24 months

Secondary Outcomes (13)

• Number of recurrent patella dislocation

  From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)

• Number of revision surgery

  From MPFL surgery to occurring revision surgery (up to 24 months)

• Number of complications (other than revision surgery, e.g. infection, wound healing disorder)

  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

  up to 24 months

• Change in International Knee Documentation Committee (IKDC)-2000 from preoperative screening, at the hospitalization time and four postoperative follow ups

  up to 24 months

Study Arms (2)

Static reconstruction technique according to Schöttle

ACTIVE COMPARATOR

Static reconstruction technique according to Schöttle

Procedure: Static reconstruction technique according to Schöttle

Dynamic reconstruction technique according to Becher

ACTIVE COMPARATOR

Dynamic reconstruction technique according to Becher

Procedure: Dynamic reconstruction technique according to Becher

Interventions

Static reconstruction technique according to Schöttle 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.

Static reconstruction technique according to Schöttle

Dynamic reconstruction technique according to Becher 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.

Dynamic reconstruction technique according to Becher

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Department of Orthopaedics and Traumatology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic

Rheinfelden, 4310, Switzerland

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Officials

• Christian Egloff, PD Dr. med.

  Department of Orthopaedics and Traumatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Egloff, PD Dr. med.

CONTACT

+41 79 75 33 72 4; christian.egloff@usb.ch

Daniel Rikli, Prof. Dr. med.

CONTACT

+41 79 75 33 72 4; daniel.rikli@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre prospective longitudinal randomized clinical trial

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: May 10, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

CH (2)