On-Table vs Off-Table Techniques for Hip Replacement

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for hip replacement surgery to determine which one is more effective. The "On Table Group" uses a special table to assist during surgery, while the "Off Table Group" relies on the surgeon to position the leg. The trial aims to identify the more efficient and effective approach. Individuals undergoing a first-time hip replacement on one hip and eligible for spinal anesthesia may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to advancements in surgical techniques for hip replacement.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these techniques are safe for hip replacement?

Research has shown that both the "on-table" and "off-table" methods for hip replacement surgery are safe. One study found that the direct anterior approach (DAA) for hip replacement can be performed safely using either a special traction table or a regular table. This indicates that patients generally handle the surgery well, regardless of the table used.

Additional research confirms that the DAA, with either method, is a safe and effective choice for hip replacement. This technique is used worldwide, and many patients have undergone these surgeries without major problems.

Prospective participants in a study for these techniques can feel confident that both methods are well-established and have been proven safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different techniques for hip replacement surgeries: the "on-table" and "off-table" methods. The "on-table" technique uses a specialized traction table to position the patient's leg, which is standard in many hospitals. In contrast, the "off-table" technique relies on a regular operating table, with the surgeon manually positioning the leg. This could potentially reduce costs by eliminating the need for specialized equipment and extra staff. By comparing these methods, researchers hope to determine which approach is more efficient and effective for patients undergoing hip replacement surgery.

What evidence suggests that this trial's techniques could be effective for hip replacement?

This trial will compare the "on-table" and "off-table" techniques for hip replacement surgery. Research has shown that both methods are effective and safe. Studies have found that the "off-table" technique may reduce setup and operation time, allowing for a quicker surgery process without compromising safety. Meanwhile, the "on-table" group will undergo surgery using a special traction table, which is also efficient and safe. Both methods are widely used globally and have proven to lead to good patient outcomes. ^{2 4 6 7 8}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35601995/

The Off-Table Technique Increases Operating Room ... Conclusion: Conversion to an off-table DAA technique offers an improvement in operating room efficiency. This is seen in setup, operative, and total room time.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2352344122000966

The Off-Table Technique Increases Operating Room ... Conversion to an off-table DAA technique offers an improvement in operating room efficiency. This is seen in setup, operative, and total room time.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04831372

On-Table Versus Off-Table Total Hip Arthroplasty We hypothesize that there will be an increase in efficiency as measured by time when performing a standard operating table (Off-Table) DAA THA when compared to ...

4. arthroplastytoday.org arthroplastytoday.org/article/S2352-3441(23)00188-7/fulltext

'On Table' Versus 'Off Table' Direct Anterior Approach Total ... The purpose of this study was to evaluate whether there were differences in patient-reported outcomes, operative times, satisfaction scores, ...

5. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-023-00198-z

Clinical outcomes of DAA and related techniques in hip ... The direct anterior approach can be an effective and safe way to perform a THA. It is the goal of this review to highlight evidence of its outcomes and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10834458/

'On Table' Versus 'Off Table' Direct Anterior Approach Total ... This study shows that the direct anterior approach for THA can be safely and efficiently performed on either a specialized traction table or a regular table.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10472647/

Clinical outcomes of DAA and related techniques in hip ... The direct anterior approach can be an effective and safe way to perform a THA. It is the goal of this review to highlight evidence of its outcomes and ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2800844

Evaluation of Comparative Efficacy and Safety of Surgical ... All surgical approaches except the direct lateral approach were associated with greater improvements of hip score when compared with the posterior approach.