Clinical trial NCT01917929: Secur-Fit Advanced Outcomes Study
Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: [E04.555.110.110.110]
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 326
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the Secur-Fit Advanced Hip Stem in primary total hip replacement surgery.

Detailed description: This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Secur-Fit Advanced Hip Stem for primary total hip arthroplasty with a cementless application in a consecutive series of patients who meet the eligibility criteria.

The primary objective of this study is to evaluate the success rate of cementless primary total hip replacement with the Secur-Fit Advanced Hip Stem. Success will be defined as absence of femoral stem revision for aseptic loosening or device-related femoral fracture at 5 years postoperative. It is expected that the success rate of the Secur-Fit Advanced Hip Stem group will be non-inferior to the selected reference rate of 99% at 5 years postoperative.

Eligibility criteria: Inclusion Criteria:

* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation.
* Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease.
* Patient is a candidate for primary total hip arthroplasty.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has previously undergone open surgical intervention on the operative hip.
* Patient has a prior femoral fracture, with or without deformity, on the operative side.
* Patient has an existing total hip replacement on the contralateral side.
* Patient requires simultaneous bilateral total hip replacement.
* Patient has a Body Mass Index (BMI) \> 45.
* Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency that would create an unacceptable risk of instability, prosthesis fixation failure or complications in postoperative care, or which limits the ability to evaluate the safety and efficacy of the device.
* Patient has bone stock that is inadequate for support or fixation of the prosthesis, or is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.

Primary outcomes:
measure: Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
timeFrame: 5 years
Secondary outcomes:
measure: All-cause Revision and Removal Rate
timeFrame: 10 years
measure: Rate of Device-related Femoral Fracture
timeFrame: 30 days
measure: Final Seating of Femoral Stem
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Spring Valley
country: United States
facility: Family Orthopedic Center
state: Illinois
city: Lawrenceville
country: United States
facility: Mercer Bucks Orthopaedics
state: New Jersey
city: Albany
country: United States
facility: OrthoNY - Everett Road Health Park
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Danville
country: United States
facility: Geisinger Orthopaedic Institute
state: Pennsylvania
Study officials:
affiliation: Tucson Orthopaedic Institute
name: Edward Petrow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Geoffrey Westrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Samuel Wellman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family Orthopaedic Center
name: Paul Perona, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Michael Dayton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Geisinger Orthopaedic Institute
name: Thomas Bowen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ortho NY
name: Frank Conguista, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercer Bucks Orthopaedics
name: Michael Ast, MD
role: PRINCIPAL_INVESTIGATOR
References: