Acetabular Shell Positioning Using Patient Specific Instruments

Rheumatoid Arthritis Clinical Trial

Official title:

Comparison of Acetabular Shell Position Using Patient Specific Instruments vs. Standard Surgical Instruments: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791738
• Other study ID #: CCF 10-1138
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2013
• Last updated: July 9, 2015
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

No further details to report.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis
• Osteoarthritis, Hip
• Rheumatoid Arthritis

Intervention

Procedure:
• Acetabular positioning system
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

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between planned and actual values of Abduction and Version.		Through 2 weeks after surgery.	No