- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06906419
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
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
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 Locations
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Drammen, Norway, 3004
- Vestre Viken HF
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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
- 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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Proportion of patients requiring additional surgical interventions after the index surgery at our institution.
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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.
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Secondary Outcome Measures
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.
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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.
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At the time of the interview, which will be performed from 1 year up to 7 years postoperatively.
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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.
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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.
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At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
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Pain Assessment
Time Frame: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
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Numeric pain rating scale (NRS), ranging from the least pain, 0, to the worst pain imaginable, 10, during daily activities.
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At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
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Patient Satisfaction
Time Frame: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
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Satisfaction score on a scale, ranging from 1 (very dissatisfied) to 5 (very satisfied).
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At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
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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.
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Incidence of recurrent patellar dislocations post-surgery.
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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.
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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.
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Frequency and type of complications following trochleoplasty.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 1, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 7, 2025
First Submitted That Met QC Criteria
March 28, 2025
First Posted (Actual)
April 2, 2025
Study Record Updates
Last Update Posted (Actual)
May 14, 2025
Last Update Submitted That Met QC Criteria
May 9, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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