Arthroplasty, Replacement, HipNCT01917929

Secur-Fit Advanced Outcomes Study

A study testing Secur-Fit Advanced Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Arthroplasty, Replacement, Hip
What is being tested?: Secur-Fit Advanced Hip Stem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 326 participants
Where: 8 sitesUnited States
Study dates: 15 Aug 2013to 13 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

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

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested: Secur-Fit Advanced Hip Stem
Keywords: [E04.555.110.110.110]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Secur-Fit Advanced Hip StemDevice
Straight femoral stem intended for cementless, press-fit application.

Study groups in NCT01917929
Study group	Role	What they receive
Secur-Fit Advanced	Other	Secur-Fit Advanced Hip Stem Receives: Device: Secur-Fit Advanced Hip Stem

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201313 Jun 2024

First posted7 Aug 2013 (estimated)
Study start15 Aug 2013
Primary completion1 May 2023
Study completion13 Jun 2024

Why it stopped: As longitudinal patient follow up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements it was intended to support. Termination is not related to any safety concerns with the product.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01917929
Sponsor's protocol ID: 75
Status last verified: Jun 2025
First submitted: 24 Jun 2013
Last updated: 23 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The restor3d Outcomes Registry
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Z1 Hip System: Post-Market Clinical Follow Up Study
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All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Secur-Fit Advanced Hip Stem
ClinicalTrials.gov ID: NCT01917929
Acronym / sponsor ID: 75
Conditions: Arthroplasty, Replacement, Hip
Keywords: [E04.555.110.110.110]
Study type: Interventional
Recruitment status: TerminatedReason stopped: As longitudinal patient follow up continues to lag, Stryker has determined that the study is no longer able to meet the regulatory requirements it was intended to support. Termination is not related to any safety concerns with the product.
Enrolment: 326 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 15 Aug 2013 (actual)
Primary completion: 1 May 2023 (actual)
Study completion: 13 Jun 2024 (actual)
First posted: 7 Aug 2013 (estimated)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Secur-Fit Advanced	Other	Device: Secur-Fit Advanced Hip StemSecur-Fit Advanced Hip Stem

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Secur-Fit Advanced Hip StemStraight femoral stem intended for cementless, press-fit application.	Device	Secur-Fit Advanced

Primary outcome

Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture
Time frame: 5 years
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.

3 secondary outcomes

All-cause Revision and Removal Rate
Time frame: 10 years
Rate of Device-related Femoral Fracture
Time frame: 30 days
Final Seating of Femoral Stem
Time frame: Intraoperative

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Secur-Fit Advanced	326	38

Primary outcome: Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture

Time frame: 5 years. Count of participants. Unit: Participants

Measure	Secur-Fit Advanced n = 314
Value	0

Population analysed: Participants/hips with available data up to 5 years or at the time of early study termination.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative Site Events	14 of 314 (4.5%)	27 of 314 (8.6%)	0 of 314
Non Operative Site Events (Systemic)	4 of 314 (1.3%)	0 of 314 (0%)	8 of 314

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Hip

RecruitingObservational study
The restor3d Outcomes Registry
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RecruitingObservational study
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Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
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Pain, Postoperative, Muscle Weakness
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward Petrow, MD principal investigator

Tucson Orthopaedic Institute

Geoffrey Westrich, MD principal investigator

Hospital for Special Surgery, New York

Samuel Wellman, MD principal investigator

Duke University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Secur-Fit Advanced Hip Stem in people with Arthroplasty, Replacement, Hip, run by Stryker Orthopaedics at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01917929.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.