Secur-Fit Advanced Outcomes Study

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

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%.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Secur-Fit Advanced Hip Stem

• Study Type: Interventional
• Enrollment (Actual): 314
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Illinois
    • Spring Valley, Illinois, United States, 61362
      • Family Orthopedic Center
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • Mercer Bucks Orthopaedics
  • New York
    • Albany, New York, United States, 12205
      • OrthoNY - Everett Road Health Park
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Secur-Fit Advanced; Secur-Fit Advanced Hip Stem	Device: Secur-Fit Advanced Hip Stem; Straight femoral stem intended for cementless, press-fit application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of revision for aseptic loosening or femoral fracture	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause revision and removal rate	10 years
Rate of femoral fracture	30 days
Component exposure or countersink upon final seating	intraoperative
Femoral head center, femoral offset and leg-length discrepancy preoperative, planned and postoperative in a subset of cases	preop, 6 weeks

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): May 1, 2023
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: August 6, 2013
• First Posted (Estimated): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: [E04.555.110.110.110]
• Other Study ID Numbers: 75