Clinical trial NCT01257568: Rejuvenate Modular Outcomes Study
Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Survival Rate of the Rejuvenate Modular Stem/Neck
timeFrame: 5 years postoperative
Secondary outcomes:
measure: Biomechanical Measurement of Femoral Offset
timeFrame: 6 weeks
measure: Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation
timeFrame: 6 weeks
measure: Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation
timeFrame: 6 weeks
measure: Mean Harris Hip Score at Each Visit
timeFrame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
measure: Mean SF-12 Scores at Each Visit
timeFrame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
measure: Mean Lower Extremity Activity Scale (LEAS) Scores at Each Visit
timeFrame: pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year
measure: Occurrence of Subsidence at Six Weeks, Stem Migration, Unstable Fixation and Radiographic Instability (Radiolucency)
timeFrame: 6 wks,1,2,3,4,5 yrs
Other outcomes:
Locations:
city: Dearborn
country: United States
facility: Oakwood Healthcare
state: Michigan
city: Sartell
country: United States
facility: St. Cloud Orthopaedics Associates
state: Minnesota
city: Tulsa
country: United States
facility: The Orthopedic Center
state: Oklahoma
Study officials:
affiliation: The Orthopedic Center
name: Yogesh Mittal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Cloud Orthopaedic Associates
name: Joseph Nessler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oakwood Healthcare System
name: Lawrence Morawa, M.D.
role: PRINCIPAL_INVESTIGATOR
References: