Secur-Fit Advanced Outcomes Study

NCT01917929 | Terminated Results

• 1 other identifier: 75
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Arthroplasty, Replacement, Hip

Keywords

[E04.555.110.110.110]

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• All-cause Revision and Removal Rate

  10 years

• Rate of Device-related Femoral Fracture

  30 days

• Final Seating of Femoral Stem

  Intraoperative

Study Arms (1)

Secur-Fit Advanced

OTHER

Secur-Fit Advanced Hip Stem

Device: Secur-Fit Advanced Hip Stem

Interventions

Secur-Fit Advanced Hip Stem DEVICE

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

Secur-Fit Advanced

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (8)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Family Orthopedic Center

Spring Valley, Illinois, 61362, United States

Location

Mercer Bucks Orthopaedics

Lawrenceville, New Jersey, 08648, United States

Location

OrthoNY - Everett Road Health Park

Albany, New York, 12205, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Geisinger Orthopaedic Institute

Danville, Pennsylvania, 17822, United States

Location

Limitations and Caveats

Given the challenges initiated by the COVID-19 pandemic and the difficulties in recalling study subjects for long-term postoperative visits, follow-up compliance saw a decline. As a result, the number of subjects available for analysis at the 10-year endpoint would be insufficient. Consequently, a business decision was made to close the study early.

Results Point of Contact

• Title: Kevin Barga, Senior Manager, Clinical Affairs
• Organization: Stryker Orthopaedics

kevin.barga@stryker.com

201-831-5000

Study Officials

• Edward Petrow, MD

  Tucson Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Geoffrey Westrich, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

• Samuel Wellman, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Paul Perona, MD

  Family Orthopaedic Center

  PRINCIPAL INVESTIGATOR

• Michael Dayton, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Thomas Bowen, MD

  Geisinger Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Frank Conguista, MD

  Ortho NY

  PRINCIPAL INVESTIGATOR

• Michael Ast, MD

  Mercer Bucks Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: August 7, 2013
• Study Start: August 15, 2013
• Primary Completion: May 1, 2023
• Study Completion: June 13, 2024
• Last Updated: July 23, 2025
• Results First Posted: November 27, 2024

Record last verified: 2025-06

Locations

US (8)