- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04849130
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation (DynMPFL)
February 15, 2024 updated by: University Hospital, Basel, Switzerland
DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
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
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Christian Egloff, PD Dr. med.
- Phone Number: +41 79 75 33 72 4
- Email: christian.egloff@usb.ch
Study Contact Backup
- Name: Daniel Rikli, Prof. Dr. med.
- Phone Number: +41 79 75 33 72 4
- Email: daniel.rikli@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Department of Orthopaedics and Traumatology, University Hospital Basel
-
Principal Investigator:
- Christian Egloff, PD Dr. med.
-
Contact:
- Christian Egloff, PD Dr. med.
- Email: christian.egloff@usb.ch
-
Sub-Investigator:
- Yves Acklin, PD Dr. med.
-
Contact:
- Ilona Ahlborn
- Email: ilona.ahlborn@usb.ch
-
Rheinfelden, Switzerland, 4310
- Recruiting
- Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic
-
Contact:
- Bertram Rieger, Dr. med.
- Email: bertram.rieger@altius.ag
-
Principal Investigator:
- Bertram Rieger, Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Kujala score
Time Frame: up to 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of recurrent patella dislocation
Time Frame: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
|
Surgical outcome: recurrent patella dislocation.
|
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)
|
Surgical outcome: 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)
Time Frame: From MPFL surgery to occurring complication (up to 24 months)
|
Surgical outcome: 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
Time Frame: up to 24 months
|
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.
|
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
|
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.
|
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
|
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).
|
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
|
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."
|
up to 24 months
|
Operation time
Time Frame: During MPFL surgery (up to 1 day)
|
Operation time
|
During MPFL surgery (up to 1 day)
|
Hospitalization time
Time Frame: During hospitalization (up to 1 month)
|
Length of hospital stay Length of hospital stay
|
During hospitalization (up to 1 month)
|
Change in gait asymmetry
Time Frame: Preoperatively and 1 year postoperative
|
Instrumented gait analysis (by EMG) on a treadmill with an embedded plantar pressure plate and on an overground walkway with two embedded force plates.
|
Preoperatively and 1 year postoperative
|
Change in isokinetic muscle strength
Time Frame: Preoperatively and 1 year postoperative
|
Muscle strength will be measured bilaterally using a dynamometer.
|
Preoperatively and 1 year postoperative
|
Change in timing of muscle activity
Time Frame: Preoperatively and 1 year postoperative
|
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.
|
Preoperatively and 1 year postoperative
|
Change in single legged drop test
Time Frame: Preoperatively and 1 year postoperative
|
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.
|
Preoperatively and 1 year postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christian Egloff, PD Dr. med., Department of Orthopaedics and Traumatology, University Hospital Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2021
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
April 7, 2021
First Submitted That Met QC Criteria
April 12, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
February 16, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
- patella dislocation
- 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-Instability-Severity (PIS) score
- dynamic reconstruction technique according to Becher
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-02701; mu21Egloff
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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