Clinical trial NCT00510458: LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-08-02
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Linear Wear Rate
timeFrame: 5 Years Post-Surgery
Secondary outcomes:
measure: Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
timeFrame: preoperative, 1, 3, and 5 years
measure: Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits
timeFrame: preop, 1, 3, and 5 Years
measure: Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.
timeFrame: preoperative, 1, 3, and 5 Years
measure: Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.
timeFrame: preop, 1, 3, and 5 Years
measure: Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
timeFrame: preoperative, 1, 3, and 5 Years
measure: Number of Hips That Dislocated
timeFrame: 3 and 5 years
measure: Number of Hips Evaluated as Radiographically Unstable
timeFrame: 1, 3, 5 years
measure: Percentage of Cases That Did Not Have Any Component Revised
timeFrame: 5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Cedars Medical Center University of Miami
state: Florida
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ocean City
country: United States
facility: Seaview Orthopedics
state: New Jersey
city: Bend
country: United States
facility: The Center: Orthopedic & Neurosurgical Care & Research
state: Oregon
city: Moon
country: United States
facility: Greater Pittsburgh Orthopaedic Associates
state: Pennsylvania
Study officials:
affiliation: Greater Pittsburgh Orthopaedic Associates
name: James D'Antonio, MD
role: STUDY_CHAIR
affiliation: Greater Pittsburgh Orthopaedic Associates
name: Stephen Thomas, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University Medical Center
name: Eric Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Seaview Orthopaedic
name: Arthur Mark, M.D.
role: PRINCIPAL_INVESTIGATOR
References: