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

Stryker

Status: Completed

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: LFIT™ Femoral Heads With X3® Insert

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510458

63

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

LFIT™Femoral Heads With X3® Insert

Other group

Description:

LFIT™ Femoral Heads With X3® Insert

Treatment:

Device: LFIT™ Femoral Heads With X3® Insert