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NCT Number: NCT04849130

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

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Traumatology, University Hospital Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Static reconstruction technique according to Schöttle

Procedure

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

Procedure

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 outcomes

  1. 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.

Secondary outcomes

  1. Number of recurrent patella dislocation

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

    Surgical outcome: recurrent patella dislocation.

  2. Number of revision surgery

    Time frame: From MPFL surgery to occurring revision surgery (up to 24 months)

    Surgical outcome: revision surgery.

  3. 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).

  4. 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.

  5. 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.

  6. 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).

  7. 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."

  8. Operation time

    Time frame: During MPFL surgery (up to 1 day)

    Operation time

  9. Hospitalization time

    Time frame: During hospitalization (up to 1 month)

    Length of hospital stay Length of hospital stay

  10. 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.

  11. Change in isokinetic muscle strength

    Time frame: Preoperatively and 1 year postoperative

    Muscle strength will be measured bilaterally using a dynamometer.

  12. 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.

  13. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Egloff, PD Dr. med.

CONTACT

[email protected]

+41 79 75 33 72 4

Daniel Rikli, Prof. Dr. med.

CONTACT

[email protected]

+41 79 75 33 72 4

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: DynMPFL

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 19, 2021
Registry last updated
Apr 22, 2025

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.

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