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Tritanium® Primary Acetabular Shell Study

Sponsored by Stryker Orthopaedics

About this trial

Last updated 2 years ago

Study ID

69

Status

Active, not recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 14 years ago

What is this trial about?

This study will be a prospective, non-randomized evaluation of the Tritanium® Acetabular Shell for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Half of the cases will use the X3® polyethylene insert alone as the bearing surface; the other half will use the MDMTM liner coupled with a compatible ADM/MDMTM X3® insert as the bearing surface. The success rate, defined as freedom from acetabular revision for any reason, for hips implanted with the Tritanium® Acetabular Shell, is no worse than for hips implanted with similar technology as reported in the literature and Trident® X3® Study historical control at 5 years postoperative.

What are the participation requirements?

Yes

Inclusion Criteria

- A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.

- B. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.

- C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).

- D. Patient is a candidate for a primary cementless total hip replacement.

- E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

No

Exclusion Criteria

- F. Patient has a Body Mass Index (BMI) ≥ 40.

- G. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

- H. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.

- I. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.

- J. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).

- K. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.

- L. Patient has a known sensitivity to device materials.

- M. Patient is a prisoner.