Real-Time Instrument for Acetabular Shell Positioning (RTI)

NeuroTherapia, Inc.

Status: Terminated

Conditions: Total Hip Arthroplasty

Treatments: Procedure: Standard Total Hip Arthroplasty; Device: Real-time Instrumentation

Study type: Interventional

Funder types: Other

Identifiers

NCT02006251

CCF 13-940

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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 anterior or posterior total hip arthroplasty
• 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Standard Total Hip Arthroplasty

Active Comparator group

Description:

Each surgeon will use their standard methods of pre-operative planning using pre-operative x-rays, and complete the procedure using standard surgical instruments for total hip arthroplasty.

Treatment:

Procedure: Standard Total Hip Arthroplasty

Real-time Instrumentation

Experimental group

Description:

Pre-operative planning through 3D software with design of real-time instrument intraoperatively using bone cement and surrogate bone model for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty

Treatment:

Procedure: Standard Total Hip Arthroplasty

Device: Real-time Instrumentation