Clinical trial NCT05154058: Medial Peel Release Technique TKA Randomized Clinical Trial
Official title: Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Total Knee Arthroplasty
Osteoarthritis, Knee
Keywords: Medial Subperiosteal Release
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2021-12-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Visual Analogue Pain Scale (VAS)
timeFrame: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
measure: Change in Oxford Knee Score (OKS)
timeFrame: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
measure: Change in Incidence of Pes bursitis
timeFrame: 3 weeks, 3 months, 6 months, and 12 months post-operatively.
Secondary outcomes:
measure: Changes in Varus valgus knee assessment
timeFrame: 3 weeks, 3 months, 6 months, and 12 months post-operatively.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Orthopaedics and Spine Center
state: Georgia
Study officials:
References: