Medial Peel Release Technique TKA Randomized Clinical Trial

Not Applicable

Terminated

• Conditions: Total Knee Arthroplasty; Osteoarthritis, Knee
• Interventions: Procedure: Medial Subperiosteal Release with Electrocautery; Procedure: Medial Subperiosteal Release with Sharp Dissection

• Registration Number: NCT05154058
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-10
• Study Start: 2022-11-02
• Primary Completion: 2023-01-18
• Study Completion: 2023-01-18
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control: electrocautery	Medial Subperiosteal Release with Electrocautery	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.
Investigational: sharp dissection.	Medial Subperiosteal Release with Sharp Dissection	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.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Pain Scale (VAS)	Before and after surgery at the 3 month, 6 month, and 12 month follow-ups	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 .
Change in Incidence of Pes bursitis	3 weeks, 3 months, 6 months, and 12 months post-operatively.	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.
Change in Oxford Knee Score (OKS)	Before and after surgery at the 3 month, 6 month, and 12 month follow-ups	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)

Secondary Outcome Measures

Name	Time	Method
Changes in Varus valgus knee assessment	3 weeks, 3 months, 6 months, and 12 months post-operatively.	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.

Trial Locations

Locations (1)

Emory Orthopaedics and Spine Center; 🇺🇸 Atlanta, Georgia, United States