On-Table vs Off-Table Techniques for Hip Replacement

Recruiting in Roanoke (>99 mi)

Overseen By Trevor M Owen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Must not be taking: Blood thinners

Disqualifiers: Bilateral procedure, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

93 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The first method is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. The major limitations associated with the traction table are the need for two additional staff members and the purchase of said table. The second method is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method.

Who Is on the Research Team?

Trevor M Owen, MD

Principal Investigator

Carilion Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a primary unilateral total hip arthroplasty (hip replacement) due to osteoarthritis. They must be able to consent and pass medical clearance. It's not for those with a BMI over 40, HbA1c levels above 8.0, pregnant women, active smokers, or anyone needing bilateral procedures or unable to have spinal anesthesia.

Inclusion Criteria

I am having a hip replacement on one side.

You are able to give informed consent.

Exclusion Criteria

BMI > 40

I cannot have spinal anesthesia due to taking blood thinners.

Failure to meet medical clearance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total hip arthroplasty using either the 'on-table' or 'off-table' method

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for pain and recovery outcomes at 2 and 6 weeks post-surgery

6 weeks

2 visits (in-person)

Long-term Follow-up

Participants are assessed for long-term outcomes at 1 year post-surgery

1 year

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Off Table Group
• On Table Group

Trial Overview The study compares two techniques of total hip replacement using the Direct Anterior Approach: 'on-table' using a traction table that positions the leg versus 'off-table' where the surgeon manually positions the leg without special equipment. Patients will be randomly assigned one of these methods.

How Is the Trial Designed?

Group I: Off Table Group Experimental Treatment 1 Intervention

The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The experimental group will be using the second method, which is the "off-table" method. In this method the patient is placed on a standard operating room table and the operative leg is manually positioned by the surgeon during the procedure . This obviates the need for the additional staff members or purchase of a specialized table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method.

Group II: On Table Group Active Control 1 Intervention

The Direct Anterior Approach (DAA) is a common way to perform total hip arthroplasty. There are two main techniques to perform total hip replacement through the anterior approach. The control group will be using the first method, which is the "on-table" method, which uses a specialized surgical table, called a traction table. This table involves placing both feet in specialized boots that are then hooked up to the table, and allows for positioning of the operative leg with aid of the table. Both the "on-table" and "off-table" techniques are routinely used both worldwide and by our joint replacement specialists at Carilion Clinic. This study will aim to compare the efficiency and efficacy of performing the DAA for total hip arthroplasty utilizing either the "on-table" or "off- table" technique. Patients will be randomized to receive their total hip arthroplasty with either the "on- table" or "off-table" method.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Tech Carilion School of Medicine and Research Institute

Collaborator

Trials

8

Recruited

530+