Study:
Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
Rationale:
n/a
Purpose:
The proposed study is a double-blinded randomized controlled trial comparing patient
specific instruments with solely standardized instruments and pre-operative planning used
for the placement of the acetabular cup prosthesis used in total hip arthroplasty.
The investigators will enroll 36 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 patient specific instruments
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. Print-offs from the pre-operative plan will also be
used in the treatment group.
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.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Osteoarthritis, Hip
Rheumatoid Arthritis
Avascular Necrosis |
Procedure: Acetabular positioning system |
Phase 1 |
Verified by
The Cleveland Clinic
February, 2013
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT01791738
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
The Cleveland Clinic
Cleveland, Ohio 44195
United States
Wael K Barsoum, MD., Principal Investigator