Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)

March 18, 2021 updated by: Hannover Medical School

Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL) - a Retrospective Case Series

In a single surgical center, 213 consecutive patients with 221 knees were surgically treated for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was performed by oblique transpatellar tunnel transfer and tenodesis screw. Follow-up data including Kujala-, BANFF- and Norwich patellar instability score as well as Return-to-Sport and pain level were collected at a minimum follow-up of 2 years

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Niedersachsen
      • Hanover, Niedersachsen, Germany, 30625
        • Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2019

Primary Completion (Actual)

April 12, 2019

Study Completion (Actual)

February 27, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Patellar Instability

3
Subscribe