Medial Peel Release Technique TKA Randomized Clinical Trial

NCT05154058 | Terminated DMC

• 1 other identifier: STUDY00003277
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Osteoarthritis, Knee

Keywords

Medial Subperiosteal Release

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Changes in Varus valgus knee assessment

  3 weeks, 3 months, 6 months, and 12 months post-operatively.

Study Arms (2)

Control: electrocautery

ACTIVE COMPARATOR

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

Investigational: sharp dissection.

ACTIVE COMPARATOR

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

Interventions

Medial Subperiosteal Release with Sharp Dissection 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

Also known as: Medial Peel

Investigational: sharp dissection.

Medial Subperiosteal Release with Electrocautery 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.

Control: electrocautery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over age 18
• Patients undergoing primary TKA for osteoarthritis

You may not qualify if:

• Patients undergoing revision TKA
• Any patients not undergoing TKA for non-OA diagnosis
• Adults unable to consent
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Orthopaedics and Spine Center

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Electrocoagulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 10, 2021
• Study Start: November 2, 2022
• Primary Completion: January 18, 2023
• Study Completion: January 18, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)