Static reconstruction technique according to Schöttle
ProcedureIn 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.
NCT Number: NCT04849130
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
Interested in participating?
Request Info14 year and older
All sexes
Interventional
Not applicable
Department of Orthopaedics and Traumatology, University Hospital Basel, Basel, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
Surgical outcome: recurrent patella dislocation.
Time frame: From MPFL surgery to occurring revision surgery (up to 24 months)
Surgical outcome: revision surgery.
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).
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.
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.
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).
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."
Time frame: During MPFL surgery (up to 1 day)
Operation time
Time frame: During hospitalization (up to 1 month)
Length of hospital stay Length of hospital stay
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.
Time frame: Preoperatively and 1 year postoperative
Muscle strength will be measured bilaterally using a dynamometer.
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.
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.
Contact information is provided by the study sponsor or research team.
Christian Egloff, PD Dr. med.
CONTACT
Daniel Rikli, Prof. Dr. med.
CONTACT
University Hospital, Basel, Switzerland
Other
DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Acronym: DynMPFL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06883396
Disease Attributes, Fractures, Bone
Redwood City, California, United States
View Trial DetailsNCT05184439
Joint Diseases, Joint Dislocations
Lodz, Poland
View Trial DetailsNCT04438109
Joint Diseases, Joint Dislocations
Hanover, Lower Saxony, Germany
View Trial DetailsNCT03983213
Joint Diseases, Joint Dislocations
Lodz, Poland
View Trial Details