Knee Pain ChronicNCT04313556
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
A study testing Lateral patellar release in people with Knee Pain Chronic, run by Hawler Medical University.
Trial summary
We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR… Read more about this study
- Who is it for?
- Ages 19 to 45 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Lateral patellar release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2016to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination
Who cannot join
- Dislocated or history of dislocation.
- Patellar instability.
- Bony abnormality (trochlear groove hypoplasia or flat).
- Osteoarthritis of the knee 3rd and 4th grades.
- Infected knee.
- Varus and valgus knee.
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- Rotational deformity of the lower extremity.
- Miserable malalignment triad.
- Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture.
- History of fracture around knee.
- Focal Osteoarthritis of the lateral facet joint.
- Chondral lesion (Outerbridge 3 and 4).
About this study
We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.
- Conditions
- Knee Pain Chronic
- Being tested
- Lateral patellar release
- Keywords
- Lateral patellar compression syndrome, Arthroscopic lateral release, Lysholm score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral patellar releaseProcedure or surgery
Arthroscopic lateral patellar reticular release
| Study group | Role | What they receive |
|---|---|---|
| Lateral patellar release | Other | Arthroscopic lateral patellar retinacular release Receives: Procedure: Lateral patellar release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm Knee Score
Eight sections are assessed to produce an overall score on a scale of 0 to 100. Then an assignment is given as "excellent" for 95 to 100 points; "good" for 85 to 94 points, "fair" for 65 to 84 points, or "poor" for less than 65 points
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start4 Dec 2016
- Primary completion1 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherwan Ahmed Ali Hamawandi, Hawler Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313556
- Sponsor's protocol ID
- HMU/Sherwan8
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome
- ClinicalTrials.gov ID
- NCT04313556
- Acronym / sponsor ID
- HMU/Sherwan8
- Conditions
- Knee Pain Chronic
- Keywords
- Lateral patellar compression syndrome, Arthroscopic lateral release, Lysholm score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 4 Dec 2016 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 18 Mar 2020 (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.
We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral patellar release | Other | Procedure: Lateral patellar releaseArthroscopic lateral patellar retinacular release |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination
Key exclusion criteria (12 listed)
- Dislocated or history of dislocation.
- Patellar instability.
- Bony abnormality (trochlear groove hypoplasia or flat).
- Osteoarthritis of the knee 3rd and 4th grades.
- Infected knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral patellar releaseArthroscopic lateral patellar reticular release | Procedure or surgery | Lateral patellar release |
Primary outcome
Lysholm Knee Score
Time frame: 12 months
Eight sections are assessed to produce an overall score on a scale of 0 to 100. Then an assignment is given as "excellent" for 95 to 100 points; "good" for 85 to 94 points, "fair" for 65 to 84 points, or "poor" for less than 65 points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral patellar release in people with Knee Pain Chronic, run by Hawler Medical University.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lysholm Knee Score (time frame: 12 months). 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 18 Mar 2020.