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

Patellar Instability Clinical Trial

— DynMPFL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849130
• Other study ID #: 2020-02701; mu21Egloff
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Christian Egloff, PD Dr. med.
• Phone: +41 79 75 33 72 4
• Email: christian.egloff[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Patellar Dislocation
• Patellar Instability

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Orthopaedics and Traumatology, University Hospital Basel	Basel
Switzerland	Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic	Rheinfelden

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of recurrent patella dislocation	Surgical outcome: recurrent patella dislocation.	From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
Secondary	Number of revision surgery	Surgical outcome: revision surgery.	From MPFL surgery to occurring revision surgery (up to 24 months)
Secondary	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).	From MPFL surgery to occurring complication (up to 24 months)
Secondary	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.	up to 24 months
Secondary	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.	up to 24 months
Secondary	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).	up to 24 months
Secondary	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."	up to 24 months
Secondary	Operation time	Operation time	During MPFL surgery (up to 1 day)
Secondary	Hospitalization time	Length of hospital stay Length of hospital stay	During hospitalization (up to 1 month)
Secondary	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.	Preoperatively and 1 year postoperative
Secondary	Change in isokinetic muscle strength	Muscle strength will be measured bilaterally using a dynamometer.	Preoperatively and 1 year postoperative
Secondary	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.	Preoperatively and 1 year postoperative
Secondary	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.	Preoperatively and 1 year postoperative