Secur-Fit Advanced Outcomes Study

NCT ID: NCT01917929

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-15
• Study Completion Date: 2024-06-13

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.

Conditions

Arthroplasty, Replacement, Hip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Secur-Fit Advanced

Secur-Fit Advanced Hip Stem

Group Type: OTHER

Secur-Fit Advanced Hip Stem

Intervention Type: DEVICE

Straight femoral stem intended for cementless, press-fit application.

Interventions

Secur-Fit Advanced Hip Stem

Straight femoral stem intended for cementless, press-fit application.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Petrow, MD

Role: PRINCIPAL_INVESTIGATOR

Tucson Orthopaedic Institute

Geoffrey Westrich, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Samuel Wellman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Paul Perona, MD

Role: PRINCIPAL_INVESTIGATOR

Family Orthopaedic Center

Michael Dayton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Thomas Bowen, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Orthopaedic Institute

Frank Conguista, MD

Role: PRINCIPAL_INVESTIGATOR

Ortho NY

Michael Ast, MD

Role: PRINCIPAL_INVESTIGATOR

Mercer Bucks Orthopaedics

Locations

Tucson Orthopaedic Institute

Tucson, Arizona, United States

University of Colorado Denver

Aurora, Colorado, United States

Family Orthopedic Center

Spring Valley, Illinois, United States

Mercer Bucks Orthopaedics

Lawrenceville, New Jersey, United States

OrthoNY - Everett Road Health Park

Albany, New York, United States

Hospital for Special Surgery

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Geisinger Orthopaedic Institute

Danville, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

75

Identifier Type: -

Identifier Source: org_study_id