Patellar DislocationNCT06906419
Arthroscopic Trochleaplasty in Chronic Relapsing Patellar Dislocations: A Follow-up Study
An observational study of Patellar Dislocation, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Dislocation
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Patellar Dislocation
- Keywords
- patellar dislocation, arthroscopic, trochleaplasty
- Medical subject headings
- Patellar Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation Rate
Proportion of patients requiring additional surgical interventions after the index surgery at our institution.
Measured: 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
Incidence of recurrent patellar dislocations post-surgery.
Measured: 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
Frequency and type of complications following trochleoplasty.
Measured: 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
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.
Measured: At the time of the interview, which will be performed from 1 year up to 7 years postoperatively.
EQ-5D-5L (HRQoL) scores
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.
Measured: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Pain Assessment
Numeric pain rating scale (NRS), ranging from the least pain, 0, to the worst pain imaginable, 10, during daily activities.
Measured: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Patient Satisfaction
Satisfaction score on a scale, ranging from 1 (very dissatisfied) to 5 (very satisfied).
Measured: At the time of the follow-up interview, which will be performed from 1 year up to 7 years postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellar DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906419
- Sponsor's protocol ID
- 1000324
- Status last verified
- May 2025
- First submitted
- 7 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluering av Kliniske Resultater Hos Pasienter Operert for Kronisk Residiverende Patellaluksasjoner Ved Hjelp av Artroskopisk Stabilisering Med Trokleaplastikk. En Kvalitetskontroll-studie
- ClinicalTrials.gov ID
- NCT06906419
- Acronym / sponsor ID
- 1000324
- Conditions
- Patellar Dislocation
- Keywords
- patellar dislocation, arthroscopic, trochleaplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
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.
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.
Functional Outcome
Time frame: 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.
Pain Assessment
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Dislocation, run by Vestre Viken Hospital Trust at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.