Total Knee ArthroplastyNCT05154058

Medial Peel Release Technique TKA Randomized Clinical Trial

A study testing Medial Subperiosteal Release with Sharp Dissection and Medial Subperiosteal Release with Electrocautery in people with Total Knee Arthroplasty and Osteoarthritis, Knee, run by Emory University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Total Knee Arthroplasty, Osteoarthritis, Knee
What is being tested?: Medial Subperiosteal Release with Sharp Dissection and Medial Subperiosteal Release with Electrocautery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2022to 18 Jan 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients over age 18
Patients undergoing primary TKA for osteoarthritis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory Orthopaedics and Spine Center
Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis

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.

Read the 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
Being tested: Medial Subperiosteal Release with Sharp Dissection, Medial Subperiosteal Release with Electrocautery
Keywords: Medial Subperiosteal Release
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medial Subperiosteal Release with Sharp DissectionProcedure or surgery
Also called Medial Peel
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
Medial Subperiosteal Release with ElectrocauteryProcedure or surgery
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.

Study groups in NCT05154058
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Medial Subperiosteal Release with Sharp Dissection

What is being measured

The primary outcome is the main question the study is designed to answer.

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 .
Measured: 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)
Measured: 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.
Measured: 3 weeks, 3 months, 6 months, and 12 months post-operatively.

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202218 Jan 2023

First posted10 Dec 2021
Study start2 Nov 2022
Primary completion18 Jan 2023
Study completion18 Jan 2023

Why it stopped: The Study was terminated due to principal investigator moving institutions

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05154058
Sponsor's protocol ID: STUDY00003277
Status last verified: Oct 2023
First submitted: 23 Nov 2021
Last updated: 27 Oct 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: At this time it will be an internal study with no sharing of de-identified patient information to third parties.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
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Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

All Total Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dissection Technique of Medial Subperiosteal Release on the Incidence of Pes Bursitis
ClinicalTrials.gov ID: NCT05154058
Acronym / sponsor ID: STUDY00003277
Conditions: Total Knee Arthroplasty, Osteoarthritis, Knee
Keywords: Medial Subperiosteal Release
Study type: Interventional
Recruitment status: TerminatedReason stopped: The Study was terminated due to principal investigator moving institutions
Enrolment: 4 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: 2 Nov 2022 (actual)
Primary completion: 18 Jan 2023 (actual)
Study completion: 18 Jan 2023 (actual)
First posted: 10 Dec 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control: electrocautery	Active comparator	Procedure: Medial Subperiosteal Release with ElectrocauteryPrimary 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.
Investigational: sharp dissection.	Active comparator	Procedure: Medial Subperiosteal Release with Sharp DissectionPrimary 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients over age 18
Patients undergoing primary TKA for osteoarthritis

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medial Subperiosteal Release with Sharp DissectionAlso: Medial PeelMedial 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	Procedure or surgery	Investigational: sharp dissection.
Medial Subperiosteal Release with ElectrocauteryMedial 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.	Procedure or surgery	Control: electrocautery

Primary outcome

Change in Visual Analogue Pain Scale (VAS)
Time frame: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
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)
Time frame: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups
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
Time frame: 3 weeks, 3 months, 6 months, and 12 months post-operatively.
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.

1 secondary outcome

Changes in Varus valgus knee assessment
Time frame: 3 weeks, 3 months, 6 months, and 12 months post-operatively.

Results and safety

The study was stopped early (reason given: The Study was terminated due to principal investigator moving institutions). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Individual participant dataSharing planned: No. At this time it will be an internal study with no sharing of de-identified patient information to third parties.

Related trials for Total Knee Arthroplasty

Active, not recruiting
14022 ATTUNE Cementless RP Clinical Performance Evaluation
Osteoarthritis
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Active, not recruiting
Healthy Living After Knee Replacement
Arthroplasty, Overweight and Obesity
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The Study was terminated due to principal investigator moving institutions). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analogue Pain Scale (VAS) (time frame: Before and after surgery at the 3 month, 6 month, and 12 month follow-ups). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05154058.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.