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

Primary Purpose

Patellar Instability

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Static reconstruction technique according to Schöttle

Dynamic reconstruction technique according to Becher

About this trial

This is an interventional treatment trial for Patellar Instability focused on measuring 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

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Orthopaedics and Traumatology, University Hospital BaselRecruiting
Department of Orthopaedics and Traumatology, Swiss Altius Medical ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Static reconstruction technique according to Schöttle

Dynamic reconstruction technique according to Becher

Arm Description

Static reconstruction technique according to Schöttle

Dynamic reconstruction technique according to Becher

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of recurrent patella dislocation

Surgical outcome: recurrent patella dislocation.

Number of revision surgery

Surgical outcome: revision surgery.

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

Surgical outcome: complications (other than revision surgery, e.g. infection, wound healing disorder).

Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups

The Banff Patella Instability Instrument (BPII) is a disease-specific health-related quality of life score. It is a patient-reported, disease-specific QOL score that consists of 23 questions across five domains covering symptoms/physical complains, work-related concerns, recreational activity and sport participation/competition, lifestyle, and social/emotional. Patients mark their answers on a visual analogue scale measuring 100 mm in length. Each item is equally weighted with the final score calculated as an average of the scores from all answered items. A higher score reflects a higher QOL.

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

The IKDC includes 18 questions covering three domains: symptoms, physical activity, and function. The items are answered on Likert scales of varying values. IKDC scores are calculated by dividing the total score by the highest possible score for the items answered, and multiplying by 100, with higher scores indicating better function.

Change in EQ-5D-5L from preoperative screening, at the hospitalization time and four postoperative follow ups EQ-5D- EQ-5D-5L

The EQ-5D descriptive system comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The five levels in each dimension are worded as (1) 'not /no problems', (2) 'slight problems', (3) 'moderate problems', (4) 'severe problems', and (5) 'unable to' (mobility, self-care, usual activities), 'extreme' (pain/depression), or 'extremely' (anxiety/depression).

Change in pain level using the numeric rating scale from preoperative screening, at the hospitalization time and four postoperative follow ups

It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."

Operation time

Hospitalization time

Length of hospital stay Length of hospital stay

Change in gait asymmetry

Instrumented gait analysis (by EMG) on a treadmill with an embedded plantar pressure plate and on an overground walkway with two embedded force plates.

Change in isokinetic muscle strength

Muscle strength will be measured bilaterally using a dynamometer.

Change in timing of muscle activity

Timing of the gracilis muscle will be assessed as on- and offset relative to the gait cycle. Gracilis onset will be determined as the time when the processed EMG signal exceeded a threshold of three standard deviations above a baseline mean and as offset, when the processed EMG signal falls below a threshold of three standard deviations above a baseline mean.

Change in single legged drop test

Standing erect upon only the tested leg with the foot in neutral position, participants will step off a 30 cm high platform placed 11 cm from the edge of the force-plate. Participants will be instructed to land in the centre of the force-plate on the tested leg only.

Full Information

NCT ID

NCT04849130

First Posted

April 7, 2021

Last Updated

September 12, 2022

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT04849130

Brief Title

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

Acronym

DynMPFL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

March 2027 (Anticipated)

Study Completion Date

March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multicentre prospective longitudinal randomized clinical trial

Masking

ParticipantOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Static reconstruction technique according to Schöttle

Arm Type

Active Comparator

Arm Description

Static reconstruction technique according to Schöttle

Arm Title

Dynamic reconstruction technique according to Becher

Arm Type

Active Comparator

Arm Description

Dynamic reconstruction technique according to Becher

Intervention Type

Procedure

Intervention Name(s)

Static reconstruction technique according to Schöttle

Intervention Description

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

Intervention Name(s)

Dynamic reconstruction technique according to Becher

Intervention Description

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 Measure Information:

Title

Change in Kujala score

Description

Time Frame

up to 24 months

Secondary Outcome Measure Information:

Title

Number of recurrent patella dislocation

Description

Surgical outcome: recurrent patella dislocation.

Time Frame

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

Title

Number of revision surgery

Description

Surgical outcome: revision surgery.

Time Frame

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

Title

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

Description

Surgical outcome: complications (other than revision surgery, e.g. infection, wound healing disorder).

Time Frame

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

Title

Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups

Description

Time Frame

up to 24 months

Title

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

Description

Time Frame

up to 24 months

Title

Change in EQ-5D-5L from preoperative screening, at the hospitalization time and four postoperative follow ups EQ-5D- EQ-5D-5L

Description

Time Frame

up to 24 months

Title

Change in pain level using the numeric rating scale from preoperative screening, at the hospitalization time and four postoperative follow ups

Description

It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."

Time Frame

up to 24 months

Title

Operation time

Description

Operation time

Time Frame

During MPFL surgery (up to 1 day)

Title

Hospitalization time

Description

Length of hospital stay Length of hospital stay

Time Frame

During hospitalization (up to 1 month)

Title

Change in gait asymmetry

Description

Instrumented gait analysis (by EMG) on a treadmill with an embedded plantar pressure plate and on an overground walkway with two embedded force plates.

Time Frame

Preoperatively and 1 year postoperative

Title

Change in isokinetic muscle strength

Description

Muscle strength will be measured bilaterally using a dynamometer.

Time Frame

Preoperatively and 1 year postoperative

Title

Change in timing of muscle activity

Description

Time Frame

Preoperatively and 1 year postoperative

Title

Change in single legged drop test

Description

Time Frame

Preoperatively and 1 year postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Egloff, PD Dr. med.

Phone

+41 79 75 33 72 4

christian.egloff@usb.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Rikli, Prof. Dr. med.

Phone

+41 79 75 33 72 4

daniel.rikli@usb.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Egloff, PD Dr. med.

Organizational Affiliation

Department of Orthopaedics and Traumatology, University Hospital Basel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Orthopaedics and Traumatology, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Egloff, PD Dr. med.

christian.egloff@usb.ch

First Name & Middle Initial & Last Name & Degree

Ilona Ahlborn

ilona.ahlborn@usb.ch

First Name & Middle Initial & Last Name & Degree

Christian Egloff, PD Dr. med.

First Name & Middle Initial & Last Name & Degree

Yves Acklin, PD Dr. med.

Facility Name

Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic

City

Rheinfelden

ZIP/Postal Code

4310

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bertram Rieger, Dr. med.

bertram.rieger@altius.ag

First Name & Middle Initial & Last Name & Degree

Bertram Rieger, Dr. med.

12. IPD Sharing Statement

Citations:

PubMed Identifier

35818060

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.

Results Reference

derived

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

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