- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07637344
Tactile Guided Lateral Patellar Release (TGLPR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Under short-acting general anesthesia, the patient lies supine. The surgeon palpates to identify the lateral border of the patella; typically, the surgeon's left thumb is placed at the midpoint of this lateral edge. Using a No. 11 scalpel blade, an incision is made parallel to the lateral border of the patella-approximately 5 mm away-extending through the skin, subcutaneous layers, and lateral retinaculum, and penetrating the knee's synovial membrane to enter the joint space. This creates a small "keyhole" opening suitable for knee arthroscopy, with the sharp edge of the blade initially oriented toward the patient's head.
The tip of the blade is then angled inward into the joint to incise the lateral retinaculum superiorly, without enlarging the initial skin puncture.
The blade is then rotated 180 degrees so that its sharp edge faces toward the patient's feet. The inferior portion is incised by angling the blade inward through the subcutaneous layers, lateral retinaculum, and synovial membrane into the joint, while maintaining the original shape and size of the skin puncture without enlargement.
A sterile dressing and a compression bandage are then applied, and the patient is encouraged to begin early mobilization.
3. Comparison of Clinical Success Rates Surgical Goal Isolated Release Release + Realignment Stability Success ~77.3% ~93.6% Recurrence Rate Higher (odds ~0.29) Lower (odds ~0.06)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Retropatellar Pain
- Lateral Patellar Pain
Exclusion Criteria:
- Knee Arthritis grade 4
- Totally Knee Arthritis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tactile Guided Lateral Patellar Release
Percutaneous lateral retinacular release of the patella
|
The lateral edge of the patella is identified by the surgeon's finger and the lateral ligament incision is performed with a blade through the skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Less open surgery trauma
Time Frame: [Time Frame: 3 minutes to 5 minutes,]
|
Directly going to the goal lesion with less expansion
|
[Time Frame: 3 minutes to 5 minutes,]
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TGLPR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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