LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
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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 |
|---|---|
|
Hip Arthropathy |
Device: LFIT™ Femoral Heads With X3® Insert |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study - An Open Label, Prospective, Post-market, Multi-center Evaluation of the LFIT™ Anatomic CoCr Femoral Heads With X3® Inserts |
- 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.
- 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.
| Estimated Enrollment: | 95 |
| 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) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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 |
| Sampling Method: | Non-Probability Sample |
Patients intending to undergo primary total hip arthroplasty with the LFIT device are invited by the investigator to participate in the study.
Inclusion Criteria:
- Patient is candidate for a primary cementless total hip replacement, and a posterolateral surgical approach is planned.
- Patient's preoperative templating predicts the use of a Hemispherical Acetabular Shell size 52mm or larger.
- 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
- Male and non-pregnant female patients age 18 years or older at time of enrollment.
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patients willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
- Patient has an active infection within the affected hip joint.
- Patient requires revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient has a Body Mass Index (BMI) ≥ 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- 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).
- Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
- Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
- Patient is a prisoner.
Contacts and 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 | |
| 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: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013