LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/17/2018 |
Start Date: | April 2007 |
End Date: | December 2016 |
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
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.
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.
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.
We found this trial at
5
sites
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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