Medial Peel Release Technique TKA Randomized Clinical Trial

NCT ID: NCT05154058

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-01-18

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.

Conditions

Total Knee Arthroplasty; Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control: 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.

Group Type: ACTIVE_COMPARATOR

Medial Subperiosteal Release with Electrocautery

Intervention Type: PROCEDURE

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.

Investigational: 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.

Group Type: ACTIVE_COMPARATOR

Medial Subperiosteal Release with Sharp Dissection

Intervention Type: PROCEDURE

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

Interventions

Medial Subperiosteal Release with Sharp Dissection

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

Intervention Type: PROCEDURE

Medial Subperiosteal Release with Electrocautery

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.

Intervention Type: PROCEDURE

Other Intervention Names

Medial Peel

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ajay Premkumar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

STUDY00003277

Identifier Type: -

Identifier Source: org_study_id