Secur-Fit Advanced Outcomes Study

Study Overview
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Brief Summary
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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 success rate of the Secur-Fit Advanced femoral stem, defined as absence of stem revision for aseptic loosening or femoral fracture, is expected to be no worse than 99% at 5 years postoperative with a non-inferiority margin of 2.5%.

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

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Secur-Fit Advanced Hip Stem


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Secur-Fit Advanced<br>Secur-Fit Advanced Hip Stem | Device: Secur-Fit Advanced Hip Stem<br>* Straight femoral stem intended for cementless, press-fit application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of revision for aseptic loosening or femoral fracture |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause revision and removal rate |  | 10 years | 
| Rate of femoral fracture |  | 30 days | 
| Component exposure or countersink upon final seating |  | intraoperative | 
| Femoral head center, femoral offset and leg-length discrepancy preoperative, planned and postoperative in a subset of cases |  | preop, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[E04.555.110.110.110]