Clinical trial NCT04317586: Trident II Revision Outcomes Study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Trident II Acetabular Shell in a Revision Indication
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Hip Revision
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2020-03-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.


Eligibility criteria: 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 18-85 years of age at the time of study device implantation.

C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.

D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusion Criteria:

E. Patient has a Body Mass Index (BMI) \> 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.

I. Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.

J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.

K. 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.

L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.

Primary outcomes:
measure: Number of Cases Free From Trident II Acetabular Shell Revision
timeFrame: 6 Weeks, 3-6 Months, 1 Year and 2 Years
Secondary outcomes:
measure: Radiographic Stability
timeFrame: 6 Weeks and 3-6 Months
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Lafayette General Orthopedic Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital Research Institute
state: Michigan
city: Mankato
country: United States
facility: The Orthopaedic & Fracture Clinic, P.A.
state: Minnesota
city: Reno
country: United States
facility: Reno Orthopedic Center Foundation
state: Nevada
city: Albany
country: United States
facility: OrthoNY
state: New York
city: New York
country: United States
facility: Syracuse Orthopedic Specialists
state: New York
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: