Secur-Fit Advanced Outcomes Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01917929
• Other study ID #: 75
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

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