NCT04438109

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

Same day

First QC Date

June 16, 2020

Last Update Submit

March 18, 2021

Conditions

Keywords

kneeMPFL reconstructionpatella instabilitypatella dislocation

Outcome Measures

Primary Outcomes (3)

  • 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)

    24 months postoperative

  • 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)

    24 months postoperative

  • 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)

    24 months postoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

April 12, 2019

Primary Completion

April 12, 2019

Study Completion

February 27, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations