An interventional study of Static reconstruction technique according to Schöttle and Dynamic reconstruction technique according to Becher in Patellar Instability, sponsored by University Hospital, Basel, Switzerland. Recruiting at 2 sites in Switzerland. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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
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.
41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 22 interventional studies indexed under Patellar Dislocation.
Browse Patellar Dislocation studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
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Clinically significant
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Static reconstruction technique according to Schöttle
Procedure: Static reconstruction technique according to Schöttle
Dynamic reconstruction technique according to Becher
Procedure: Dynamic reconstruction technique according to Becher
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.
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.
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.
Time frame: up to 24 months
Number of recurrent patella dislocation
Surgical outcome: recurrent patella dislocation.
Time frame: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
Number of revision surgery
Surgical outcome: 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)
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)
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.
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
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.
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
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).
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
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
Operation time
Operation time
Time frame: During MPFL surgery (up to 1 day)
Hospitalization time
Length of hospital stay Length of hospital stay
Time frame: During hospitalization (up to 1 month)
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.
Time frame: Preoperatively and 1 year postoperative
Change in isokinetic muscle strength
Muscle strength will be measured bilaterally using a dynamometer.
Time frame: Preoperatively and 1 year postoperative
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.
Time frame: Preoperatively and 1 year postoperative
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.
Time frame: Preoperatively and 1 year postoperative
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