N/A
N=40
Rejuvenate Modular Outcomes Study
Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT01257568 ↗Enrolled (actual)
40
Serious AEs
35.4%
Results posted
Jan 2019
Primary outcome: Primary: Survival Rate of the Rejuvenate Modular Stem/Neck — 8 Surviving Hips
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rejuvenate Modular Hip (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stryker Orthopaedics
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate of the Rejuvenate Modular Stem/Neck |
8 | — |
| SECONDARY Biomechanical Measurement of Femoral Offset |
-2 | — |
| SECONDARY Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation |
-4 | — |
| SECONDARY Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation |
— | — |
| SECONDARY Mean Harris Hip Score at Each Visit |
55.48; 69.88; 94.25; 89.92; 90.83; 90.82 | — |
| SECONDARY Mean SF-12 Scores at Each Visit |
33.26; 37.07; 51.98; 46.83; 50.15; 49.04 | — |
| SECONDARY Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit |
8.88; 7.45; 11.32; 11.18; 11.85; 11.29 | — |
| SECONDARY Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency) |
5; 4; 4; 6; 4; 0 | — |
Summary
This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.
Eligibility Criteria
Inclusion Criteria
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
- Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
- Patient is a candidate for a primary cementless total hip replacement.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- Patient's operative femur templates to Rejuvenate® Modular Stem size 7-12.
Exclusion Criteria
- Patient has a Body Mass Index (BMI) ≥ 40.
- 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, which limits the ability to evaluate the safety and efficacy of the device.
- Patient 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 requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint.
- Patient has a known sensitivity to device materials.
- Patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT01257568). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.