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Acetabular positioning system · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| Acetabular positioning system | EXPERIMENTAL | 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 |
| Standard total hip arthroplasty | NO_INTERVENTION | 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. |
| Name | Type | Description |
|---|---|---|
| Acetabular positioning system | PROCEDURE | 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 |
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 C...
Acetabular positioning system is used for osteoarthritis of the hip. It is an investigational device being studied in a clinical trial for patients with hip osteoarthritis, as well as rheumatoid arthritis and avascular necrosis. The device is intended to assist in positioning the acetabular shell during hip surgery.
Acetabular positioning system is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker symbol CYH. The company is conducting clinical research on this device for hip osteoarthritis.
Acetabular positioning system is in Phase 1 clinical development. It is an investigational device, meaning it has not been approved by the FDA and is still being studied in clinical trials. The Phase 1 trial has been completed.
Acetabular positioning system has one completed clinical trial, identified as NCT01791738, titled "Acetabular Shell Positioning Using Patient Specific Instruments." This Phase 1 study enrolled 36 participants in the United States and included patients with hip osteoarthritis, rheumatoid arthritis, and avascular necrosis.
Acetabular positioning system is not the same as patient specific instruments. The clinical trial NCT01791738 is titled "Acetabular Shell Positioning Using Patient Specific Instruments," which indicates that patient specific instruments are used as part of the procedure involving the acetabular positioning system.