On-Table Versus Off-Table Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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BACKGROUND: The Direct Anterior Approach (DAA) for total hip arthroplasty (THA) has become increasingly popular in the US over the last decade (Berry & Bozic, 2010). Major limitations of the DAA with traction table include the need for an additional surgeon's assistant, a traction table operator, and the purchase of said table. To counter these limitations, some surgeons advocate for the performing the DAA with a conventional operating room table {Cohen, 2017;Molenaers, 2017}. However to date, there are no studies directly comparing the efficiency and efficacy of these two techniques for DAA. OBJECTIVE: Currently, it is unclear which surgical technique is more efficient and effective for total hip arthroplasties (THA). 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 a purpose built traction table (On-Table) DAA THA. In addition, there will be less pain and faster functional recovery in the early post-operative period for patients who underwent an Off-Table DAA THA when compared to an On-Table DAA THA. SPECIFIC AIMS: 1) Determine whether there is a difference in operating room efficiency between surgeries after a THA via DAA with a standard OR table versus a purpose-built traction table; 2) examine whether there is a difference in early post-operative pain and clinical outcomes when comparing patients who underwent a THA via the DAA with a standard OR table versus a purpose built traction table. 3) report differences in complication rates between those two. METHODS: This is a prospective randomized clinical trial that will evaluate adult patients admitted to Carilion Clinic undergoing primary unilateral total hip arthroplasty. Off and on table DAA procedures will be performed by a single surgeon with multiple years of training and experience in both. Cluster randomization will be performed where patients will be randomized through scheduling. Demographic data will be collected. Operative records will be used to record operative times for each approach. Radiographs to assess implant positioning on postoperative day 0. The primary outcome variables are intra-operative data such as time the patient enters the operating room, time of incision, time of dressing application, exit room time, implants used, operative report. For secondary outcome variables, we will assess at 2 and 6 week follow ups routine Patient-Reported Outcome Measures including narcotic utilization based on pill count and MEq, and the PROMIS and HOOS, JR. measures. EXPECTED OUTCOMES: We expect that the Off-table DAA technique will be associated with faster set up, surgical time, and overall room time when compared to the On-table approach. Additionally, we expect less early post-operative pain in the groin, knee and ankle. We expect that the patient report outcome measures at 2 and 6 weeks post-op for the off-table DAA group will be equivalent or better than the on-table DAA group. Finally we expect no difference in complication rate.

Official Title
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Comparing On-Table vs Off-Table Total Hip Arthroplasty Via the Direct Anterior Approach: A Prospective Randomized Trial

Conditions
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Arthroplasty, Replacement, Hip, Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: Off Table Group
* Procedure: On Table Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing primary unilateral THA Patient 18 years of age and older Patients who are able to provide consent Exclusion Criteria: Bilateral procedure Non-Primary arthroplasty Prior non-arthroplasty operation requiring removal of hardware Inability to have spinal anesthesia (blood thinners) BMI > 40 Active Smoking HbA1c > 8.0 Failure to meet medical clearance Pregnant women per standard of care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Primary Objectives- Determine whether there is a difference in operating room efficiency when preparing for, positioning, performing and turning over an operating room after a total hip arthroplasty (THA) via the direct anterior approach (DAA) when using a purpose built traction table (On-Table) vs a standard operating table (Off-Table)? Secondary Objective- Examine whether there is a difference in early post-operative pain, mobilization, complication rates and clinical outcomes when comparing patients who underwent a THA via the DAA when using an On-Table vs Off-Table technique.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On Table Group<br>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. | Procedure: On Table Group<br>* Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table<br>|
| Experimental: Off Table Group<br>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. | Procedure: Off Table Group<br>* Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Set Up Time | Time point that patient enters room to time point of first incision | Time point that patient enters room to time point of first incision | 
| Surgery Time | Time point of first incision to time point of dress application | Time point of first incision to time point of dress application | 
| Takedown Time | Time point of Dress application to Time point of exiting operating room | Time point of Dress application to Time point of exiting operating room | 
| Total Room Time | Time point that patient enters room to time point of exiting operating room | Time point that patient enters room to time point of exiting operating room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System/Hip Disability and Osteoarthritis Outcome Score, Joint Replacement scores | Hip pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = extreme pain | pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op | 
| Visual Analog Scale scores | Hip, knee, ankle pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = worst pain | pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op | 
| Narcotic Utillization | Measured by pill count usage and converted into MME | 2 weeks post op pill count | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Off table, Direct anterior approach, Hip arthroplasty, On table