NCT06906419

Brief Summary

This study aims to evaluate the long-term clinical outcomes of arthroscopic trochleoplasty in patients treated for chronic recurrent patellar dislocations. The primary objective is to assess the effectiveness of the procedure in reducing the need for re-operations and preventing recurrent instability. Secondary objectives include evaluating postoperative complications, patellofemoral pain, functional outcomes using the Kujala Anterior Knee Pain Scale (AKPS), and quality of life measured by EQ-5D-5L. This retrospective cohort study will analyze data from patient records and structured telephone interviews conducted at least one year post-surgery.

Trial Health

55
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

8 months

First QC Date

March 7, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

patellar dislocationarthroscopictrochleaplasty

Outcome Measures

Primary Outcomes (1)

  • Re-operation Rate

    Proportion of patients requiring additional surgical interventions after the index surgery at our institution.

    The investigators seek to register any re-operations from the time between the index surgery and the interview, ranging from 1 year up to 7 years postoperatively.

Secondary Outcomes (6)

  • Recurrent Instability Rate

    The investigators seek to register any incidences of recurrent instability from the time between the index surgery and the interview, ranging from 1 year up to 7 years postoperatively.

  • Postoperative Complications

    The investigators seek to register any complications related to the index surgery from the time between the index surgery and the interview, ranging from 1 year up to 7 years postoperatively.

  • Functional Outcome

    At the time of the interview, which will be performed from 1 year up to 7 years postoperatively.

  • EQ-5D-5L (HRQoL) scores

    At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.

  • Pain Assessment

    At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.

  • +1 more secondary outcomes

Eligibility Criteria

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

This retrospective cohort study evaluates the long-term outcomes of arthroscopic trochleoplasty performed to stabilize the patella in patients with chronic recurrent dislocations. The procedure involves deepening the trochlea femoris to enhance patellar tracking and prevent lateral dislocation. In some cases, medial patellofemoral ligament (MPFL) reconstruction was also performed. Data will be collected through patient medical records and structured telephone interviews, focusing on re-operation rates, postoperative complications, pain levels, functional outcomes, and quality of life. The study seeks to provide insights into the effectiveness and safety of this surgical technique, aiming to optimize treatment protocols for patellar instability.

You may qualify if:

  • Patients aged 18 years and older.
  • Underwent arthroscopic trochleoplasty for chronic recurrent patellar dislocations.
  • Surgery performed between 2015 and 2023.
  • Availability of follow-up data and consent for participation.

You may not qualify if:

  • Concurrent knee surgeries unrelated to trochleoplasty.
  • Previous surgeries on the same knee.
  • Other significant orthopedic conditions affecting the knee.
  • Lack of follow-up data or consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestre Viken HF

Drammen, 3004, Norway

Location

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Design

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

Study Record Dates

First Submitted

March 7, 2025

First Posted

April 2, 2025

Study Start

May 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations