LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00510458
First received: August 1, 2007
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

Total hip replacement surgery is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. The purpose of the study is to evaluate a large size (36mm, 40mm or 44mm) femoral (hip) head called the LFIT™ Anatomic CoCr Femoral Head (Low Friction Ion Treatment). The large size femoral heads will be used with the Trident® X3® polyethylene (plastic) inserts and will be compared with a historical control. Study Hypothesis: The linear wear rate for hips implanted with the LFIT™ Anatomic CoCr Femoral Head is no worse than 0.08 mm wear per year at 5 years post-surgery.


Condition Intervention
Arthroplasty, Replacement, Hip
Device: LFIT™ Femoral Heads With X3® Insert

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Clinical Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Linear Wear Rates [ Time Frame: 5 Years Post-Surgery ] [ Designated as safety issue: No ]
    To evaluate the linear wear rates of X3® polyethylene inserts mated with LFIT™ Anatomic CoCr Femoral Heads at 5 years postoperative. It is expected that the mean linear wear rate is not more than 0.08 mm per year or 0.05 mm per year superior to the reference control, which was 0.13 mm per year. The reference control was determined from the control group within the Post-approval Study of the ABC and Trident® Systems.


Secondary Outcome Measures:
  • Clinical and Patient Outcomes [ Time Frame: 1, 3, and 5 Years Post-Surgery ] [ Designated as safety issue: No ]
    Evaluate the preoperative and postoperative cases for quality of life, clinical results and radiographic stability. Evaluate dislocation rates at 3 and 5 years postoperative.


Enrollment: 96
Study Start Date: April 2007
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
Device: LFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
  2. Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
  3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD). Patient must have diagnosis of osteoarthritis (OA), traumatic arthritis (TA), avascular necrosis (AVN), slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation, or diastrophic variant
  4. Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
  5. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
  6. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

  1. Patient has an active infection within the affected hip joint.
  2. Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
  3. Patient has a Body Mass Index (BMI) ≥ 40.
  4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
  5. Patient is diagnosed with systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (i.e. Paget's disease, renal osteodystrophy, rheumatoid arthritis).
  6. Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
  7. Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
  8. Patient is a prisoner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510458

Locations
United States, Florida
Cedars Medical Center University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New Jersey
Seaview Orthopedics
Ocean, New Jersey, United States, 07712
United States, Oregon
The Center: Orthopedic & Neurosurgical Care & Research
Bend, Oregon, United States, 97701
United States, Pennsylvania
Greater Pittsburgh Orthopaedic Associates
Moon Township, Pennsylvania, United States, 15108
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: James D'Antonio, MD Greater Pittsburgh Orthopaedic Associates
Principal Investigator: Stephen Thomas, M.D. Greater Pittsburgh Orthopaedic Associates
Principal Investigator: Eric Smith, M.D. Tufts University Medical Center
Principal Investigator: Arthur Mark, M.D. Seaview Orthopaedic
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00510458     History of Changes
Other Study ID Numbers: 63
Study First Received: August 1, 2007
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014