The Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT01791738
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.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 1
Cleveland, Ohio, 44195, United States
No further details to report.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
Pre-operative planning through 3D software with design and fabrication of patient specific instruments for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty
Time frame: Through 2 weeks after surgery.
The Cleveland Clinic
Other
Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
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