- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04438109
Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)
Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL) - a Retrospective Case Series
Study Overview
Status
Conditions
Detailed Description
Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction. The included surgeries were performed from 07/2010 to 12/2016 in a single orthopedic hospital.
Inclusion criteria:
- Dynamic MPFL-reconstruction (primary and revision surgery) including cartilage procedure
- Age of 18 years or older at a minimum of 24 months follow up
Exclusion criteria:
- Diagnosis of connective tissue disease
- Neurological diseases including patella associated spasticity and
Concomitant alignment correction surgery including femoral/tibial osteotomy, trochleoplasty and tibial tubercle transfer
213 Patients with 221 knees (8 bilateral) met the inclusion criteria. All patients were contacted by mail or phone to independently answer questionnaires.
Surgical technique:
The technique was performed according to the description by Ostermeier et al.. Briefly, the gracilis tendon is detached at its insertion site at the pes anserinus after opening the sartorius fascia. Instead of transferring the tendon through a subligamentous tunnel of the medial collateral ligament, as detailed in the original description of the technique, the tendon was passed around the incised sartorius fascia. From around the sartorius fascia the gracilis tendon is shuttled subcutaneously to the medial patellar margin, allowing the sartorius fascia to act as a pulley for the transferred tendon. Due to the dynamic reconstruction technique, the course of the graft appears to be more oblique compared to the static technique with femoral fixation at Schöttle's point. Fixation of the tendon is achieved by passing it through a transpatellar drill hole extending from the proximal medial patellar margin to the lateral patellar margin. The tendon is then tensioned with the knee in 30 degrees of flexion and fixed with a bioabsorbable tenodesis screw.
Data collection was performed by self-administered questionnaires, which were sent to the patients.
The medical records and radiographs of all patients were reviewed for demographic information (age, sex) and to identify complications related to the surgical procedure. Complications were categorized as major if the patient returned to the operating room or required hospitalization after the index procedure. Complications were categorized as minor complications if they were treated on an outpatient basis.
Rating of the results was performed using the Kujala score, the Norwich Patellar Instability Score and the BANFF Score.
Pain level was recorded using the visual analogue scale (VAS, 0 = no pain, 10 = severe pain). General satisfaction with treatment outcomes was evaluated by questionnaire (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor, 6 = very poor) and by asking patients whether they would undergo the procedure again. Furthermore, information on patient characteristics, recurrence of dislocation, revision surgery, and other postoperative complications were recorded.
Postoperative x-rays were analyzed concerning intraoperative complications (e.g. fractures or patellar drill hole malpositioning).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Niedersachsen
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Hanover, Niedersachsen, Germany, 30625
- Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with MPFL reconstruction and possible accompanying interventions
- Age >18 years
Exclusion Criteria:
- Known hereditary connective tissue diseases (e.g. Ehlers-Danlos syndrome)
- Known neurogenic diseases
- Significant further musculoskeletal disorders
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kujala score
Time Frame: 24 months postoperative
|
The Kujala Anterior Knee Pain Scale is a patient reported assessment of patellofemoral disorders that assesses subjective symptoms and functional limitations. The score consists of 13 questions that add up to a total of 100 points. Minimum: 0 (worst), Maximum: 100 (best) |
24 months postoperative
|
Norwich Patellar Instability Score (NPI Score)
Time Frame: 24 months postoperative
|
The Norwich Patellar Instability Score is a patient reported assessment of patellofemoral instability. The score consists of 19 questions with a special weighting for every question. The results are presented in percent. Range: 0% (best) to 100% (worst) |
24 months postoperative
|
BANFF Score
Time Frame: 24 months postoperative
|
The Banff Score is a patient reported assessment of patellofemoral disorders that assesses patella instability. The score consists of 23 questions. Minimum: 0 (worst), Maximum: 100 (best) |
24 months postoperative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8262_BO_K_2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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