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On-Table Versus Off-Table Total Hip Arthroplasty

Primary Purpose

Arthroplasty, Replacement, Hip, Osteoarthritis, Hip

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Off Table Group
On Table Group
Sponsored by
Carilion Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Hip focused on measuring Direct anterior approach, Hip arthroplasty, On table, Off table

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carilion Institute for Orthopaedics & NeurosciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

On Table Group

Off Table Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Set Up Time
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
Takedown Time
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

Secondary Outcome Measures

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
Visual Analog Scale scores
Hip, knee, ankle pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = worst pain
Narcotic Utillization
Measured by pill count usage and converted into MME

Full Information

First Posted
April 1, 2021
Last Updated
April 27, 2021
Sponsor
Carilion Clinic
Collaborators
Virginia Tech Carilion School of Medicine and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04831372
Brief Title
On-Table Versus Off-Table Total Hip Arthroplasty
Official Title
Comparing On-Table vs Off-Table Total Hip Arthroplasty Via the Direct Anterior Approach: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2021 (Actual)
Primary Completion Date
April 10, 2023 (Anticipated)
Study Completion Date
April 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic
Collaborators
Virginia Tech Carilion School of Medicine and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Hip, Osteoarthritis, Hip
Keywords
Direct anterior approach, Hip arthroplasty, On table, Off table

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
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.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
On Table Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Off Table Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Off Table Group
Intervention Description
Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table
Intervention Type
Procedure
Intervention Name(s)
On Table Group
Intervention Description
Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table
Primary Outcome Measure Information:
Title
Set Up Time
Description
Time point that patient enters room to time point of first incision
Time Frame
Time point that patient enters room to time point of first incision
Title
Surgery Time
Description
Time point of first incision to time point of dress application
Time Frame
Time point of first incision to time point of dress application
Title
Takedown Time
Description
Time point of Dress application to Time point of exiting operating room
Time Frame
Time point of Dress application to Time point of exiting operating room
Title
Total Room Time
Description
Time point that patient enters room to time point of exiting operating room
Time Frame
Time point that patient enters room to time point of exiting operating room
Secondary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information System/Hip Disability and Osteoarthritis Outcome Score, Joint Replacement scores
Description
Hip pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = extreme pain
Time Frame
pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op
Title
Visual Analog Scale scores
Description
Hip, knee, ankle pain measure survey on a scale of 0 - 10 with 0 = no pain and 10 = worst pain
Time Frame
pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op
Title
Narcotic Utillization
Description
Measured by pill count usage and converted into MME
Time Frame
2 weeks post op pill count

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trevor M Owen, MD
Phone
(540) 510-6200
Email
tmowen@carilionclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trevor M Owen, MD
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Institute for Orthopaedics & Neurosciences
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trevor Owen, MD
Phone
540-510-6200
Email
tmowen@carilionclinic.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to do so.
Citations:
PubMed Identifier
30852068
Citation
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.
Results Reference
background
PubMed Identifier
19576399
Citation
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.
Results Reference
background
PubMed Identifier
15062700
Citation
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.
Results Reference
background
PubMed Identifier
20580196
Citation
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.
Results Reference
background
PubMed Identifier
28511947
Citation
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.
Results Reference
background
PubMed Identifier
16330993
Citation
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.
Results Reference
background
PubMed Identifier
28087159
Citation
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.
Results Reference
background
PubMed Identifier
18555653
Citation
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.
Results Reference
background
PubMed Identifier
25157041
Citation
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.
Results Reference
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PubMed Identifier
20378307
Citation
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.
Results Reference
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PubMed Identifier
30448326
Citation
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.
Results Reference
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On-Table Versus Off-Table Total Hip Arthroplasty

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