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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01917929
Other study ID # 75
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 1, 2013
Est. completion date May 1, 2028

Study information

Verified date April 2024
Source Stryker Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 success rate of the Secur-Fit Advanced femoral stem, defined as absence of stem revision for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years postoperative with a non-inferiority margin of 2.5%.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 314
Est. completion date May 1, 2028
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Secur-Fit Advanced Hip Stem
Straight femoral stem intended for cementless, press-fit application.

Locations

Country Name City State
United States OrthoNY - Everett Road Health Park Albany New York
United States University of Colorado Denver Aurora Colorado
United States Geisinger Orthopaedic Institute Danville Pennsylvania
United States Duke University Medical Center Durham North Carolina
United States Mercer Bucks Orthopaedics Lawrenceville New Jersey
United States Hospital for Special Surgery New York New York
United States Family Orthopedic Center Spring Valley Illinois
United States Tucson Orthopaedic Institute Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of revision for aseptic loosening or femoral fracture 5 years
Secondary All-cause revision and removal rate 10 years
Secondary Rate of femoral fracture 30 days
Secondary Component exposure or countersink upon final seating intraoperative
Secondary Femoral head center, femoral offset and leg-length discrepancy preoperative, planned and postoperative in a subset of cases preop, 6 weeks
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