NCT02006251

Real-Time Instrument for Acetabular Shell Positioning

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

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Real-time Instrumentation	To prepare the acetabulum and place the implants on the day of surgery, surgeons will receive either parts necessary to create the real-time with a surrogate model of the acetabular surface or standard surgical alignment instruments provided by the manufacturer of the implant. For the experimental group, the surgeon will be provided with 3 parts necessary to create the real-time instrument: (1) a patient-specific surrogate bone model with a built-in guide pin trajectory which was planned in the 3D planning software, (2) a non-specific plastic arm available in different sizes, and (3) bone cement. The real-time instrument is created to position a peripheral guide wire on the acetabular rim to serve as a visual aid for reaming and impacting the acetabular shell using standard reaming tools supplied by the manufacturer. Once the acetabular shell is placed, the procedure is performed in the same manner for both groups, using the standard manufacturer instruments.
PROCEDURE	Standard Total Hip Arthroplasty	Total hip arthroplasty performed according to standard of care

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2013-12-10
• Last updated: 2023-01-10
• Results posted: 2022-07-01

Locations

1 site across 1 country: United States