Acetabular Shell Positioning Using Patient Specific Instruments
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | April 2012 |
Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial
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.
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.
No further details to report.
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 direct lateral or posterior THA
- 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:
- The following criteria will exclude subjects from this protocol:
- 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.
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