Medial Peel Release Technique TKA Randomized Clinical Trial

Emory University

Status: Terminated

Conditions: Total Knee Arthroplasty; Osteoarthritis, Knee

Treatments: Procedure: Medial Subperiosteal Release with Electrocautery; Procedure: Medial Subperiosteal Release with Sharp Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT05154058

STUDY00003277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Control: electrocautery

Active Comparator group

Description:

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.

Treatment:

Procedure: Medial Subperiosteal Release with Electrocautery

Investigational: sharp dissection.

Active Comparator group

Description:

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.

Treatment:

Procedure: Medial Subperiosteal Release with Sharp Dissection