On-Table Versus Off-Table Total Hip Arthroplasty

NCT04831372 | Active Not Recruiting DMC

• 1 other identifier: IRB-20-1004
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Hip; Osteoarthritis, Hip

Keywords

Direct anterior approach; Hip arthroplasty; On table; Off table

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Patient Reported Outcomes Measurement Information System/Hip Disability and Osteoarthritis Outcome Score, Joint Replacement scores

  pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op

• Visual Analog Scale scores

  pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op

• Narcotic Utillization

  2 weeks post op pill count

Study Arms (2)

On Table Group

ACTIVE COMPARATOR

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

Off Table Group

EXPERIMENTAL

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

Interventions

Off Table Group PROCEDURE

Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table

Off Table Group

On Table Group PROCEDURE

Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table

On Table Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing primary unilateral THA
• Patient 18 years of age and older
• Patients who are able to provide consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Tech Carilion School of Medicine and Research Institute: collaborator

Study Sites (1)

Carilion Institute for Orthopaedics & Neurosciences

Roanoke, Virginia, 24014, United States

Location

Related Publications (11)

• Abdel MP, Berry DJ. Current Practice Trends in Primary Hip and Knee Arthroplasties Among Members of the American Association of Hip and Knee Surgeons: A Long-Term Update. J Arthroplasty. 2019 Jul;34(7S):S24-S27. doi: 10.1016/j.arth.2019.02.006. Epub 2019 Feb 12.

  PMID: 30852068 BACKGROUND

• Bender B, Nogler M, Hozack WJ. Direct anterior approach for total hip arthroplasty. Orthop Clin North Am. 2009 Jul;40(3):321-8. doi: 10.1016/j.ocl.2009.01.003.

  PMID: 19576399 BACKGROUND

• Berger RA. Mini-incision total hip replacement using an anterolateral approach: technique and results. Orthop Clin North Am. 2004 Apr;35(2):143-51. doi: 10.1016/S0030-5898(03)00111-1.

  PMID: 15062700 BACKGROUND

• Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. J Arthroplasty. 2010 Sep;25(6 Suppl):2-4. doi: 10.1016/j.arth.2010.04.033. Epub 2010 Jul 1.

  PMID: 20580196 BACKGROUND

• Cohen EM, Vaughn JJ, Ritterman SA, Eisenson DL, Rubin LE. Intraoperative Femur Fracture Risk During Primary Direct Anterior Approach Cementless Total Hip Arthroplasty With and Without a Fracture Table. J Arthroplasty. 2017 Sep;32(9):2847-2851. doi: 10.1016/j.arth.2017.04.020. Epub 2017 Apr 21.

  PMID: 28511947 BACKGROUND

• Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.

  PMID: 16330993 BACKGROUND

• Molenaers B, Driesen R, Molenaers G, Corten K. The Direct Anterior Approach for Complex Primary Total Hip Arthroplasty: The Extensile Acetabular Approach on a Regular Operating Room Table. J Arthroplasty. 2017 May;32(5):1553-1559. doi: 10.1016/j.arth.2016.12.016. Epub 2016 Dec 22.

  PMID: 28087159 BACKGROUND

• Nakata K, Nishikawa M, Yamamoto K, Hirota S, Yoshikawa H. A clinical comparative study of the direct anterior with mini-posterior approach: two consecutive series. J Arthroplasty. 2009 Aug;24(5):698-704. doi: 10.1016/j.arth.2008.04.012. Epub 2008 Jun 13.

  PMID: 18555653 BACKGROUND

• Post ZD, Orozco F, Diaz-Ledezma C, Hozack WJ, Ong A. Direct anterior approach for total hip arthroplasty: indications, technique, and results. J Am Acad Orthop Surg. 2014 Sep;22(9):595-603. doi: 10.5435/JAAOS-22-09-595.

  PMID: 25157041 BACKGROUND

• Restrepo C, Parvizi J, Pour AE, Hozack WJ. Prospective randomized study of two surgical approaches for total hip arthroplasty. J Arthroplasty. 2010 Aug;25(5):671-9.e1. doi: 10.1016/j.arth.2010.02.002. Epub 2010 Apr 8.

  PMID: 20378307 BACKGROUND

• Tian S, Goswami K, Manrique J, Blevins K, Azboy I, Hozack WJ. Direct Anterior Approach Total Hip Arthroplasty Using a Morphometrically Optimized Femoral Stem, a Conventional Operating Table, Without Fluoroscopy. J Arthroplasty. 2019 Feb;34(2):327-332. doi: 10.1016/j.arth.2018.10.023. Epub 2018 Oct 26.

  PMID: 30448326 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Trevor M Owen, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: BLINDING: none It is impossible to blind the surgeon to the arm as the techniques and instruments required for on-table vs off-table are substantially different. All subjects will be patients of Dr. Owen and he is the only operating surgeon for this study. The patient will see the beds when they are rolled into the operating room and are positioned. Thorough informed consent will make it apparent which table they are using.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 7, 2021
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2025
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)