Secur-Fit Advanced Outcomes Study

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

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

Study Overview

• Status: Terminated
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Secur-Fit Advanced Hip Stem

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.

• Study Type: Interventional
• Enrollment (Actual): 326
• 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	Measure Description	Time Frame
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture	The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Revision and Removal Rate	To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature.	10 years
Rate of Device-related Femoral Fracture	To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature.	30 days
Final Seating of Femoral Stem	To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating.	Intraoperative

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Geoffrey Westrich, MD, Hospital for Special Surgery, New York; Principal Investigator: Thomas Bowen, MD, Geisinger Orthopaedic Institute; Principal Investigator: Michael Dayton, MD, University of Colorado, Denver; Principal Investigator: Samuel Wellman, MD, Duke University; Principal Investigator: Edward Petrow, MD, Tucson Orthopaedic Institute; Principal Investigator: Paul Perona, MD, Family Orthopaedic Center; Principal Investigator: Frank Conguista, MD, Ortho NY; Principal Investigator: Michael Ast, MD, Mercer Bucks Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2013
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): June 13, 2024

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): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

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