Medial Peel Release Technique TKA Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. This is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. The intervention will be randomly assigning subjects undergoing TKA into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.

Detailed Description
-----------------
Medial release is a commonly performed technique to improve surgical exposure and aid in joint balancing. It is thought to be linked to the postoperative incidence of pes bursitis. However, the effect of scalpel vs electrocautery techniques for subperiosteal release has not been examined for their potential effect on the rates of pes bursitis. This randomized clinical trial will assign patients undergoing TKA for osteoarthritis (OA) into either scalpel or electrocautery release groups for their operation and will be followed postoperatively at 3 weeks and 3,6, and 12 months in order to determine the effect of release technique on rates of pes bursitis. This study will take place at Emory Orthopaedics. Subjects will not be compensated. Patients presenting to the clinic for evaluation of TKA will be screened for their eligibility in this study and recruited as well as consented in the clinic. This study can advance current clinical knowledge by evaluating two common surgical techniques to determine which may lead to better outcomes for patients undergoing TKA, a common orthopedic procedure, and reduce dissatisfaction as well as pain following operation.

Official Title
-----------------
Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis

Conditions
-----------------
Total Knee Arthroplasty, Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Procedure: Medial Subperiosteal Release with Sharp Dissection
* Procedure: Medial Subperiosteal Release with Electrocautery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over age 18 Patients undergoing primary TKA for osteoarthritis Exclusion Criteria: Patients undergoing revision TKA Any patients not undergoing TKA for non-OA diagnosis Adults unable to consent Pregnant women Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: electrocautery<br>Primary patients with Osteoarthritis (OA) undergoing Total Knee arthroplasty (TKA) will be randomly assigned into either the control or investigational group. The control arm of the study will undergo medial sub periosteal release with electrocautery. | Procedure: Medial Subperiosteal Release with Electrocautery<br>* Medial subperiosteal release - a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This group will receive this procedure using electrocautery.<br>|
| Active Comparator: Investigational: sharp dissection.<br>Primary patients with OA undergoing TKA will be randomly assigned into either the control or investigational group. The investigational arm will undergo medial sub periosteal release using sharp dissection. | Procedure: Medial Subperiosteal Release with Sharp Dissection<br>* Medial subperiosteal release - a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. This is commonly performed both via scalpel (aka sharp medial peel) or electrocautery<br>* Other names: Medial Peel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Pain Scale (VAS) | The visual analog scale (VAS) is a tool used to measure pain. Patients will be asked to indicate their perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge . | Before and after surgery at the 3 month, 6 month, and 12 month follow-ups | 
| Change in Oxford Knee Score (OKS) | The Oxford Knee Score (OKS) is a 12-item patient-reported outcomes (PRO) specifically designed and developed to assess function and pain after total knee replacement (TKR) surgery (arthroplasty) | Before and after surgery at the 3 month, 6 month, and 12 month follow-ups | 
| Change in Incidence of Pes bursitis | All patients will be seen post-operatively to monitor their progress and minimize risks, and the diagnosis of pes bursitis will be determined through clinical exam. | 3 weeks, 3 months, 6 months, and 12 months post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Varus valgus knee assessment | This assessment checks the lateral and medial collateral ligaments (ligaments on either side of the knee joint that help in back and forth movement of knee). In this test, the study doctor will hold the patient's knee joint with one hand and the ankle joint with the other, and moves the patient's leg sideways to asses the ligaments. | 3 weeks, 3 months, 6 months, and 12 months post-operatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medial Subperiosteal Release