Knee ArthroscopyNCT04130412
Open Versus Arthroscopic Release for Lateral Patellar Compression Syndrome: Comparative Study
A study testing open release in people with Knee Arthroscopy, run by Hawler Medical University.
Trial summary
Chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "Lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as… Read more about this study
- Who is it for?
- Ages 25 to 46 years
- Conditions the study is for
- Knee Arthroscopy
- What is being tested?
- open release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2016to 25 Nov 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 25 to 46 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy.
Who cannot join
- Smoking
- Patellar instability
- D.M 4. Knee osteoarthritis
- 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity
About this study
Chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "Lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as knee flexion progresses. Eighty patients were involved in this study, and it was divided into 2 random groups; Group A (40 patients)(odd number) were treated with open release after diagnostic arthroscopy and Group B (40 patients)(even number) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy. All patients were followed by Lysholm knee scaling score before surgery and two weeks , six weeks then 6 months after surgery.
Read the detailed description
This study was done by two orthopedic surgeons working in three hospitals from March 2016 to April 2018, Eighty patients were involved in this study, and it was divided into 2 matched groups; Group A (40 patients) were treated with open release after diagnostic arthroscopy and Group B (40 patients) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI ( figure 1)and diagnostic arthroscopy. All patients were followed by Lysol knee scaling score before surgery , two weeks , six weeks then 6 months after surgery. The two groups are matched related to age and gender. 52 patients are females and age ranged from 21-48 years.
Exclusion criteria are 1. Smoking 2.Patellar instability 3. D.M 4. Knee osteoarthritis 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity
- Conditions
- Knee Arthroscopy
- Being tested
- open release
- Keywords
- Lateral patellar compression syndrome, Arthroscopic release, Open release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open releaseProcedure or surgery
Also called Arthroscopic release
Open release of lateral retinaculae
| Study group | Role | What they receive |
|---|---|---|
| Open release of lateral retinaculae | Active comparator | This group was treated by open release of lateral retinaculae after diagnosis of lateral compression syndrome by arthroscopy Receives: Procedure: open release |
| Arthroscopic release of lateral retinaculae | Active comparator | This group was treated by arthroscopic release Receives: Procedure: open release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm knee scaling score
Measurement of knee pain and daily activities
Measured: All patients were followed by Lysholm knee scaling score 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start5 Mar 2016
- Primary completion10 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT04130412
- Sponsor's protocol ID
- HMU/Sherwan5
- Status last verified
- Jun 2020
- First submitted
- 13 Oct 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamawandi SA, Amin HI, Al-Humairi AK. Open versus arthroscopic release for lateral patellar compression syndrome: a randomized-controlled trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):1-7. doi: 10.1007/s00402-021-03878-0. Epub 2021 Apr 7.
PubMed 33829300
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Arthroscopic Release for Lateral Patellar Compression Syndrome: Comparative Study
- ClinicalTrials.gov ID
- NCT04130412
- Acronym / sponsor ID
- HMU/Sherwan5
- Conditions
- Knee Arthroscopy
- Keywords
- Lateral patellar compression syndrome, Arthroscopic release, Open release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 5 Mar 2016 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 17 Oct 2019 (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.
Chronic anterior knee pain with a stable patella is often associated with overload and increased pressure on the lateral facet due to pathologic lateral soft-tissue restraints. "Lateral pressure in flexion" is a term describing the pathologic process of increasing contact pressure over the lateral patellar facet as knee flexion progresses. Eighty patients were involved in this study, and it was divided into 2 random groups; Group A (40 patients)(odd number) were treated with open release after diagnostic arthroscopy and Group B (40 patients)(even number) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy. All patients were followed by Lysholm knee scaling score before surgery and two weeks , six weeks then 6 months after surgery.
Detailed description
This study was done by two orthopedic surgeons working in three hospitals from March 2016 to April 2018, Eighty patients were involved in this study, and it was divided into 2 matched groups; Group A (40 patients) were treated with open release after diagnostic arthroscopy and Group B (40 patients) were treated by arthroscopic release. All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI ( figure 1)and diagnostic arthroscopy. All patients were followed by Lysol knee scaling score before surgery , two weeks , six weeks then 6 months after surgery. The two groups are matched related to age and gender. 52 patients are females and age ranged from 21-48 years.
Exclusion criteria are 1. Smoking 2.Patellar instability 3. D.M 4. Knee osteoarthritis 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open release of lateral retinaculae | Active comparator | Procedure: open releaseThis group was treated by open release of lateral retinaculae after diagnosis of lateral compression syndrome by arthroscopy |
| Arthroscopic release of lateral retinaculae | Active comparator | Procedure: open releaseThis group was treated by arthroscopic release |
Who may qualify
- Ages
- 25 to 46 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All these patients are diagnosed as lateral patellar compression syndrome depending on clinical features, MRI and diagnostic arthroscopy.
Key exclusion criteria (4 listed)
- Smoking
- Patellar instability
- D.M 4. Knee osteoarthritis
- 5. Previous knee surgery 6. Knee deformities involving Varus , valgus or recurvatum 7. Ligament laxity
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 |
|---|---|---|
| open releaseAlso: Arthroscopic releaseOpen release of lateral retinaculae | Procedure or surgery | Arthroscopic release of lateral retinaculae, Open release of lateral retinaculae |
Primary outcome
Lysholm knee scaling score
Time frame: All patients were followed by Lysholm knee scaling score 6 months after surgery.
Measurement of knee pain and daily activities
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 4 Jun 2020.
- Derived from this study: PubMed 33829300Hamawandi SA, Amin HI, Al-Humairi AK. Open versus arthroscopic release for lateral patellar compression syndrome: a randomized-controlled trial. Arch Orthop Trauma Surg. 2022 Oct;142(10):1-7. doi: 10.1007/s00402-021-03878-0. Epub 2021 Apr 7.
- 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 open release in people with Knee Arthroscopy, 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 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: finished, as of the sponsor's last update on 4 Jun 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 scaling score (time frame: All patients were followed by Lysholm knee scaling score 6 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130412, which also lists 1 linked publication.
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 4 Jun 2020.