LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
Completed · Not applicable
Conditions studied: Arthroplasty, Replacement, Hip
In brief
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.
Key facts
- Study ID
- NCT00510458
- Run by
- Stryker Orthopaedics
- People needed
- 89
- Starts
- 2007-04-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2018-03-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Patient is a male or non-pregnant female age 18 years or older at time of enrollment.
- Patient has signed an IRB approved, study specific Informed Patient Consent Form.
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
You may not qualify if…
- 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.
Where it is running
- Cedars Medical Center University of Miami — Miami, Florida, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Seaview Orthopedics — Ocean City, New Jersey, United States
- The Center: Orthopedic & Neurosurgical Care & Research — Bend, Oregon, United States
- Greater Pittsburgh Orthopaedic Associates — Moon Township, Pennsylvania, United States
Full record on ClinicalTrials.gov
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