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CompletedNCT04438109Updated Mar 19, 2021

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

An observational study in Patellar Luxation and Patellar Instability, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Hannover Medical School · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
152
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Patellar Luxation
  • Patellar Instability

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Keywords

  • knee
  • MPFL reconstruction
  • patella instability
  • patella dislocation
03

In context

Patellar Dislocation

41 studies on the registry are indexed under Patellar Dislocation; 9 are open to participants now.

This study's enrollment of 152 is above the median of 100 across 15 observational studies indexed under Patellar Dislocation.

Browse Patellar Dislocation studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with MPFL reconstruction and possible accompanying interventions
  • Age >18 years

Exclusion criteria

Exclusion Criteria:

  • Known hereditary connective tissue diseases (e.g. Ehlers-Danlos syndrome)
  • Known neurogenic diseases
  • Significant further musculoskeletal disorders
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
152 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Kujala score

    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)

    Time frame: 24 months postoperative

  2. Norwich Patellar Instability Score (NPI Score)

    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)

    Time frame: 24 months postoperative

  3. BANFF Score

    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)

    Time frame: 24 months postoperative

07

Study locations

1 site
  • Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
    Hanover, Niedersachsen 30625, Germany
08

References and documents

Publications

  • Horstmann H, Karkosch R, Berg A, Becher C, Petri M, Smith T. The novel dynamic MPFL-reconstruction technique: cheaper and better? Arch Orthop Trauma Surg. 2022 Aug;142(8):2011-2017. doi: 10.1007/s00402-021-04198-z. Epub 2021 Oct 11. PubMed 34633513 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04438109
Responsible party
Sponsor
First posted
Jun 18, 2020
Start date
Apr 12, 2019
Primary completion
Apr 12, 2019
Completion
Feb 27, 2021
Last update
Mar 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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