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Hip Stem

Secur-Fit Hip Stem for Hip Replacement

N/A

Waitlist Available

Research Sponsored by Stryker Orthopaedics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease

Patient is a male or non-pregnant female, skeletally mature and age 21-75 years at time of study device implantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study Summary

This trial is testing a new hip stem for primary hip arthroplasty. The success rate is expected to be at least 99% at 5 years.

Who is the study for?

This trial is for adults aged 21-75 with non-inflammatory degenerative joint disease needing a hip replacement. They must be able to follow the study's procedures and visits. Excluded are those with BMI >45, existing or bilateral hip replacements, infections, neuromuscular issues affecting stability, inadequate bone stock, systemic diseases like Lupus, excessive steroid use (>30 days), material sensitivities, prior surgeries or fractures on the affected hip.Check my eligibility

What is being tested?

The Secur-Fit Advanced Hip Stem is being tested in patients undergoing primary total hip arthroplasty without cement. The goal is to see if this new device can achieve a success rate of no less than 99% at five years post-operation when compared to standard treatments within a margin of 2.5%.See study design

What are the potential side effects?

While specific side effects aren't listed for this device trial, typical risks may include pain at the implant site, infection risk from surgery, possible inflammation around the new joint and complications that could lead to further surgery such as loosening or fracture.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of arthritis that is not caused by inflammation.

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I am between 21 and 75 years old, not pregnant, and fully grown.

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I am a candidate for a first-time hip replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of revision for aseptic loosening or femoral fracture

Secondary outcome measures

All-cause revision and removal rate

Component exposure or countersink upon final seating

Femoral head center, femoral offset and leg-length discrepancy preoperative, planned and postoperative in a subset of cases

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Secur-Fit AdvancedExperimental Treatment1 Intervention

Secur-Fit Advanced Hip Stem

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stryker OrthopaedicsLead Sponsor

77 Previous Clinical Trials

19,919 Total Patients Enrolled

Media Library

Secur-Fit Advanced Hip Stem (Hip Stem) Clinical Trial Eligibility Overview. Trial Name: NCT01917929 — N/A

Hip Replacement Research Study Groups: Secur-Fit Advanced

Hip Replacement Clinical Trial 2023: Secur-Fit Advanced Hip Stem Highlights & Side Effects. Trial Name: NCT01917929 — N/A

Secur-Fit Advanced Hip Stem (Hip Stem) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01917929 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more opportunities to join this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, which commenced on August 1st 2013, is presently recruiting participants; 326 patients are needed from 6 sites."

Answered by AI

Is there an opportunity for me to take part in this clinical investigation?

"This clinical trial seeks 326 individuals with non-inflammatory degenerative joint disease and are between 21 to 75 years old. To be accepted, the patient must sign an IRB/EC approved informed consent form, they must not be pregnant females and should have a willingness to comply with postoperative evaluations as well as rehabilitation requirements."

Answered by AI

What is the total count of facilities administering this trial?

"The 6 sites for this study span from Tucson to Danville and Albany. To reduce the strain of travelling, it is recommended that potential participants choose a clinic in their vicinity."

Answered by AI

What is the cap on participants involved in this research venture?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this study, which was initially posted on August 1st 2013, is actively recruiting participants. Around 326 patients must be recruited from 6 distinct medical sites."

Answered by AI

Is the age requirement for this experiment limited to those over 30 years?

"Patients aged 21 to 75 that wish to take part in this trial must meet the inclusion criteria. Additionally, there are two trials for minors and twenty-six options available to seniors over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Secur-Fit Advanced Outcomes Study

2013. "Secur-Fit Advanced Outcomes Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01917929.

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