- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04831372
On-Table Versus Off-Table Total Hip Arthroplasty
Comparing On-Table vs Off-Table Total Hip Arthroplasty Via the Direct Anterior Approach: A Prospective Randomized Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Trevor M Owen, MD
- Phone Number: (540) 510-6200
- Email: tmowen@carilionclinic.org
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24014
- Carilion Institute for Orthopaedics & Neurosciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: On Table Group
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. |
Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table
|
Experimental: Off Table Group
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. |
Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Set Up Time
Time Frame: Time point that patient enters room to time point of first incision
|
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 Frame: Time point of first incision to time point of dress application
|
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 Frame: Time point of Dress application to Time point of exiting operating room
|
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 Frame: 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
|
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
Time Frame: pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op
|
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
Time Frame: pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op
|
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
Time Frame: 2 weeks post op pill count
|
Measured by pill count usage and converted into MME
|
2 weeks post op pill count
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Trevor M Owen, MD, Carilion Clinic
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-20-1004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Hip
-
Istituto Ortopedico RizzoliRecruiting
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
CHU de ReimsCompleted
-
Royan InstituteCompletedHip OsteoarthritisIran, Islamic Republic of
-
Daiichi Sankyo, Inc.TerminatedSymptomatic Hip OsteoarthritisFrance
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Oxford University Hospitals NHS TrustCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthroplasty | Hip ArthroplastyUnited Kingdom
-
University of ArkansasCompletedKnee Osteoarthritis | Hip Osteoarthritis | Knee Arthritis | Hip ArthritisUnited States
-
Johan KarrholmCompletedPrimary Osteoarthritis of Hip Nos | Secondary Osteoarthritis of Hip
-
Lawson Health Research InstituteCompletedHip Osteoarthritis | Hip ArthroplastyCanada
Clinical Trials on On Table Group
-
Royal Brompton & Harefield NHS Foundation TrustCompletedCommon Bile Duct StonesUnited Kingdom
-
Oslo University HospitalNot yet recruitingPeripheral Neuropathy | Intraoperative Complications | Intraoperative Injury | Patient Positioning | Operating Table
-
Centre Chirurgical Marie LannelongueCompletedPatients Are Recruited From One Thoracic and Cardiac Surgery ICUFrance
-
Viewray Inc.Active, not recruitingPancreatic CancerUnited States, Israel
-
Gaylord Hospital, IncConnecticut Community FoundationEnrolling by invitationStroke | Traumatic Brain Injury | Neurologic Disorder | Acquired Brain InjuryUnited States
-
McMaster UniversityAgency for Healthcare Research and Quality (AHRQ); Grading of Recommendations...Completed
-
University of Sao PauloCompleted
-
Istinye UniversityCompletedDrain Site ComplicationTurkey
-
Gazi UniversityCompleted
-
University Hospital PadovaCompletedAsphyxia | Newborn Morbidity | ResuscitationItaly