Patellar InstabilityDynMPFLNCT04849130
Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
A study testing Static reconstruction technique according to Schöttle and Dynamic reconstruction technique according to Becher in people with Patellar Instability, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Patellar Instability
- What is being tested?
- Static reconstruction technique according to Schöttle and Dynamic reconstruction technique according to Becher
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 May 2021to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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°
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- Instability of the cruciate or collateral ligaments
- Known significant musculoskeletal disease
- Cognitive impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Department of Orthopaedics and Traumatology, University Hospital Basel
Basel, 4031
Christian Egloff, PD Dr. med., christian.egloff@usb.ch
Ilona Ahlborn, ilona.ahlborn@usb.ch
- Recruiting
Department of Orthopaedics and Traumatology, Swiss Altius Medical Clinic
Rheinfelden, 4310
Bertram Rieger, Dr. med., bertram.rieger@altius.ag
Bertram Rieger, Dr. med.
About this study
Official title: 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
Read the 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.
- Conditions
- Patellar Instability
- Being tested
- Static reconstruction technique according to Schöttle, Dynamic reconstruction technique according to Becher
- Keywords
- 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 dislocation, Patella-Instability-Severity (PIS) score, dynamic reconstruction technique according to Becher
- Medical subject headings
- Patellar Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static reconstruction technique according to SchöttleProcedure or surgery
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 BecherProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Static reconstruction technique according to Schöttle | Active comparator | Static reconstruction technique according to Schöttle Receives: Procedure: Static reconstruction technique according to Schöttle |
| Dynamic reconstruction technique according to Becher | Active comparator | Dynamic reconstruction technique according to Becher Receives: Procedure: Dynamic reconstruction technique according to Becher |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 months
Secondary outcomes (13)
Number of recurrent patella dislocation
Surgical outcome: recurrent patella dislocation.
Measured: From MPFL surgery to occurring recurrent patella dislocation (up to 24 months)
Number of revision surgery
Surgical outcome: revision surgery.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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."
Measured: up to 24 months
Operation time
Operation time
Measured: During MPFL surgery (up to 1 day)
Hospitalization time
Length of hospital stay Length of hospital stay
Measured: 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.
Measured: Preoperatively and 1 year postoperative
Change in isokinetic muscle strength
Muscle strength will be measured bilaterally using a dynamometer.
Measured: 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.
Measured: 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.
Measured: Preoperatively and 1 year postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start10 May 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar InstabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre prospective longitudinal randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Egloff, PD Dr. med., Principal investigator, Department of Orthopaedics and Traumatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849130
- Sponsor's protocol ID
- 2020-02701; mu21Egloff
- Acronym
- DynMPFL
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartsch A, Nuesch C, Rieger B, Mundermann A, Egloff C. Dynamic versus static medial patellofemoral ligament reconstruction technique in the treatment of recurrent patellar dislocation: a randomized clinical trial protocol. J Orthop Surg Res. 2022 Jul 10;17(1):345. doi: 10.1186/s13018-022-03158-6.
PubMed 35818060
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
- ClinicalTrials.gov ID
- NCT04849130
- Acronym / sponsor ID
- DynMPFL / 2020-02701; mu21Egloff
- Conditions
- Patellar Instability
- Keywords
- 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 dislocation, Patella-Instability-Severity (PIS) score, dynamic reconstruction technique according to Becher
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentre prospective longitudinal randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Static reconstruction technique according to Schöttle | Active comparator | Procedure: Static reconstruction technique according to SchöttleStatic reconstruction technique according to Schöttle |
| Dynamic reconstruction technique according to Becher | Active comparator | Procedure: Dynamic reconstruction technique according to BecherDynamic reconstruction technique according to Becher |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static reconstruction technique according to SchöttleIn 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. | Procedure or surgery | Static reconstruction technique according to Schöttle |
| Dynamic reconstruction technique according to BecherDynamic 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. | Procedure or surgery | Dynamic reconstruction technique according to Becher |
Primary outcome
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.
13 secondary outcomes
Number of recurrent patella dislocation
Time frame: 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)
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)
Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups
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
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
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
Time frame: up to 24 months
Operation time
Time frame: During MPFL surgery (up to 1 day)
Hospitalization time
Time frame: During hospitalization (up to 1 month)
Change in gait asymmetry
Time frame: Preoperatively and 1 year postoperative
Change in isokinetic muscle strength
Time frame: Preoperatively and 1 year postoperative
Change in timing of muscle activity
Time frame: Preoperatively and 1 year postoperative
Change in single legged drop test
Time frame: Preoperatively and 1 year postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 35818060Bartsch A, Nuesch C, Rieger B, Mundermann A, Egloff C. Dynamic versus static medial patellofemoral ligament reconstruction technique in the treatment of recurrent patellar dislocation: a randomized clinical trial protocol. J Orthop Surg Res. 2022 Jul 10;17(1):345. doi: 10.1186/s13018-022-03158-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Egloff, PD Dr. med. principal investigator
Department of Orthopaedics and Traumatology, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static reconstruction technique according to Schöttle and Dynamic reconstruction technique according to Becher in people with Patellar Instability, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Egloff, PD Dr. med. (+41 79 75 33 72 4, christian.egloff@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Kujala score (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04849130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.