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On-Table vs Off-Table Techniques for Hip Replacement

N/A

Waitlist Available

Led By Trevor M Owen, MD

Research Sponsored by Carilion Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients undergoing primary unilateral THA

Patient 18 years of age and older

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will compare the efficiency and efficacy of performing the Direct Anterior Approach for total hip arthroplasty utilizing either the "on-table" or "off-table" technique.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not specified but may include typical risks associated with surgery such as pain at the incision site, infection risk, blood clots, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a hip replacement on one side.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op, 2 weeks post-op, 6 weeks post op, 1 year post op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Set Up Time

Surgery Time

Takedown Time

+1 more

Secondary outcome measures

Narcotic Utillization

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

Visual Analog Scale scores

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Off Table GroupExperimental Treatment1 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 GroupActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Tech Carilion School of Medicine and Research InstituteOTHER

6 Previous Clinical Trials

2,465 Total Patients Enrolled

Carilion ClinicLead Sponsor

70 Previous Clinical Trials

12,622 Total Patients Enrolled

2 Trials studying Osteoarthritis

274 Patients Enrolled for Osteoarthritis

Trevor M Owen, MDPrincipal InvestigatorCarilion Clinic

Media Library

Off Table Group Clinical Trial Eligibility Overview. Trial Name: NCT04831372 — N/A

Osteoarthritis Research Study Groups: On Table Group, Off Table Group

Osteoarthritis Clinical Trial 2023: Off Table Group Highlights & Side Effects. Trial Name: NCT04831372 — N/A

Off Table Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04831372 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what size is the participant pool of this study limited?

"Affirmative. Clinicaltrials.gov states that this research is currently recruiting volunteers; it first appeared on April 7th 2021 and was amended most recently on the 27th of April 2021. The trial requires 130 participants to be recruited from 1 location."

Answered by AI

Are researchers still enrolling patients for this investigation?

"Affirmative. Clinicaltrials.gov data shows that this clinical trial, which was launched on April 7th 2021, is currently recruiting participants. A total of 130 patients must be enrolled from 1 medical centre."

Answered by AI