Rejuvenate Modular Outcomes Study

NCT01257568 | Completed Results

• 1 other identifier: 68
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

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.

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• Survival Rate of the Rejuvenate Modular Stem/Neck

  The success rate is defined as freedom from Rejuvenate Modular femoral stem/neck construct revision/removal for any reason.

  5 years postoperative

Secondary Outcomes (7)

• Biomechanical Measurement of Femoral Offset

  6 weeks

• Biomechanical Measurement of the Vertical Distance of the Planned Hip Center of Rotation

  6 weeks

• Biomechanical Measurement of the Horizontal Distance of the Planned Hip Center of Rotation

  6 weeks

• Mean Harris Hip Score at Each Visit

  pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year

• Mean SF-12 Scores at Each Visit

  pre-op, 6 wk, 1, 2, 3, 4, 5, 7 year

Study Arms (1)

Rejuvenate Modular Hip System

OTHER

Rejuvenate Modular Hip

Device: Rejuvenate Modular Hip

Interventions

Rejuvenate Modular Hip DEVICE

Rejuvenate Modular Hip

Rejuvenate Modular Hip System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (3)

Oakwood Healthcare

Dearborn, Michigan, 48124, United States

Location

St. Cloud Orthopaedics Associates

Sartell, Minnesota, 56377, United States

Location

The Orthopedic Center

Tulsa, Oklahoma, 74104, United States

Location

Limitations and Caveats

Primary Outcome Note: Due to the large number of terminations and halting enrollment early in the study, the primary endpoint analysis will not be performed.

Results Point of Contact

• Title: Shaherah Yancy, Director, Clinical Operations
• Organization: Stryker Orthopaedics

shaherah.yancy@stryker.com

901-650-6601

Study Officials

• Yogesh Mittal, M.D.

  The Orthopedic Center

  PRINCIPAL INVESTIGATOR

• Joseph Nessler, M.D.

  St. Cloud Orthopaedic Associates

  PRINCIPAL INVESTIGATOR

• Lawrence Morawa, M.D.

  Oakwood Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 9, 2010
• Study Start: November 1, 2010
• Primary Completion: June 6, 2017
• Study Completion: January 20, 2022
• Last Updated: February 16, 2022
• Results First Posted: January 24, 2019

Record last verified: 2022-02

Locations

US (3)