Medial Peel Release Technique TKA Randomized Clinical Trial
Primary Purpose
Total Knee Arthroplasty, Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medial Subperiosteal Release with Sharp Dissection
Medial Subperiosteal Release with Electrocautery
Sponsored by
About this trial
This is an interventional prevention trial for Total Knee Arthroplasty focused on measuring Medial Subperiosteal Release
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
Sites / Locations
- Emory Orthopaedics and Spine CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control: electrocautery
Investigational: sharp dissection.
Arm 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.
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.
Outcomes
Primary Outcome Measures
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 .
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)
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.
Secondary Outcome Measures
Changes in Varus valgus knee assessment
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05154058
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty, Osteoarthritis, Knee
Keywords
Medial Subperiosteal Release
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control: electrocautery
Arm Type
Active Comparator
Arm 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.
Arm Title
Investigational: sharp dissection.
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Medial Subperiosteal Release with Sharp Dissection
Other Intervention Name(s)
Medial Peel
Intervention Description
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
Intervention Name(s)
Medial Subperiosteal Release with Electrocautery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Visual Analogue Pain Scale (VAS)
Description
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 .
Time Frame
Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
Title
Change in Oxford Knee Score (OKS)
Description
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)
Time Frame
Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
Title
Change in Incidence of Pes bursitis
Description
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.
Time Frame
3 weeks, 3 months, 6 months, and 12 months post-operatively.
Secondary Outcome Measure Information:
Title
Changes in Varus valgus knee assessment
Description
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.
Time Frame
3 weeks, 3 months, 6 months, and 12 months post-operatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sam Vojdani, MD
Phone
404-778-3350
Email
sam.vojdani@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Fuqua
Phone
615-767-6174
Email
andrew.fuqua@emory.edu
Facility Information:
Facility Name
Emory Orthopaedics and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sam Vojdani, MD
Phone
404-778-3350
Email
sam.vojdani@emory.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
At this time it will be an internal study with no sharing of de-identified patient information to third parties.
Learn more about this trial
Medial Peel Release Technique TKA Randomized Clinical Trial
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