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Clinical Trials/NCT02006251
NCT02006251
Terminated
Not Applicable

Comparison of Acetabular Shell Position Using Real-Time Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial

The Cleveland Clinic1 site in 1 country24 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
The Cleveland Clinic
Enrollment
24
Locations
1
Primary Endpoint
Difference Between Planned and Actual Values of Abduction
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty.

The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments.

The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
May 2014
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wael Barsoum

Vice-chairman, Department of Orthopaedic Surgery

The Cleveland Clinic

Eligibility Criteria

Inclusion Criteria

  • Subjects to be included in this protocol will be adult males and females of all races and socioeconomic status meeting the following criteria:
  • Primary, unilateral anterior or posterior total hip arthroplasty
  • 18 to 85 years old at time of surgery
  • Able to get a pre- and post-operative CT scan at the Cleveland Clinic

Exclusion Criteria

  • Significant metal in the joint that results in metal artifact on the pre--operative CT scan, thereby compromising the ability to visualize the acetabulum on the pre-operative simulator.
  • Pregnancy
  • Incarceration
  • Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being.

Outcomes

Primary Outcomes

Difference Between Planned and Actual Values of Abduction

Time Frame: Through 2 weeks after surgery.

The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.

Secondary Outcomes

  • Difference Between Planned and Actual Values of Version(Through 2 weeks after surgery)
  • Difference in the Time for Acetabular Preparation and Shell Placement Between the Two Groups(Intraoperatively (during surgery))

Study Sites (1)

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