- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342166
Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty (PD)
Effect of Patellar Denervation on Post-operative Knee Pain and Knee Function in Total Knee Arthroplasty: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, double-blind randomized controlled trial conducted at Queen Savang Vadhana Memorial Hospital between 2023 and 2025. The aim of the study is to assess the effect of patellar denervation using electrocautery on postoperative knee pain and knee function in patients undergoing primary total knee arthroplasty (TKA) without patellar resurfacing.
Sixty-four patients were enrolled and randomly assigned to either the patellar denervation group (PD) or the non-denervation group (NPD), with 32 participants in each group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Changwat Chon Buri
-
Chon Buri, Changwat Chon Buri, Thailand, 20110
- Chalathorn Kulthonchalanan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 55-85 years old
- Knee osteoarthritis
- Plan for total knee arthroplasty after failed conservative treatment for at least 3 months
Exclusion Criteria:
- Previous history of trauma, fracture or open surgery on the same knee
- Inflammatory arthritis or Crystal-induced arthritis
- Patellar instability or isolated patellofemoral osteoarthritis
- Unable to answer questionnaire
- Cannot tolerate surgery due to medical comorbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patellar Denervation
|
Electrocautery patella circumferentially during total knee arthroplasty
|
|
No Intervention: Non-Patellar Denervation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visual analog scale score for knee pain
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, and 12 months
|
2 weeks, 6 weeks, 3 months, 6 months, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kujala score
Time Frame: 3 months, 1 year
|
3 months, 1 year
|
|
Knee Society score
Time Frame: 3 months, 1 year
|
3 months, 1 year
|
|
Timed up and go test
Time Frame: 3 months, 1 year
|
3 months, 1 year
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 021/2566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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