Arthroscopic Trochleaplasty in Chronic Relapsing Patellar Dislocations: A Follow-up Study

May 9, 2025 updated by: Vestre Viken Hospital Trust

Evaluering av Kliniske Resultater Hos Pasienter Operert for Kronisk Residiverende Patellaluksasjoner Ved Hjelp av Artroskopisk Stabilisering Med Trokleaplastikk. En Kvalitetskontroll-studie

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Drammen, Norway, 3004
        • Vestre Viken HF

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Re-operation Rate
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Functional Outcome
Time Frame: At the time of the interview, which will be performed from 1 year up to 7 years postoperatively.
Kujala Anterior Knee Pain Scale (AKPS) scores assessing pain and knee function. The Kujala Score or Anterior Knee Pain Scale (AKPS) is a 13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The AKPS is graded on a scale of 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.
At the time of the interview, which will be performed from 1 year up to 7 years postoperatively.
EQ-5D-5L (HRQoL) scores
Time Frame: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
EQ-5D-5L (HRQoL) scores evaluating general health and well-being. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Pain Assessment
Time Frame: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Numeric pain rating scale (NRS), ranging from the least pain, 0, to the worst pain imaginable, 10, during daily activities.
At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Patient Satisfaction
Time Frame: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Satisfaction score on a scale, ranging from 1 (very dissatisfied) to 5 (very satisfied).
At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Recurrent Instability Rate
Time Frame: 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.
Incidence of recurrent patellar dislocations post-surgery.
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
Time Frame: 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.
Frequency and type of complications following trochleoplasty.
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.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vestre Viken Hospital Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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