- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510458
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert Study (LFIT)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Cedars Medical Center University of Miami
-
-
Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
-
New Jersey
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Ocean City, New Jersey, United States, 07712
- Seaview Orthopedics
-
-
Oregon
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Bend, Oregon, United States, 97701
- The Center: Orthopedic & Neurosurgical Care & Research
-
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Pennsylvania
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Moon, Pennsylvania, United States, 15108
- Greater Pittsburgh Orthopaedic Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: LFIT™Femoral Heads With X3® Insert
LFIT™ Femoral Heads With X3® Insert
|
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Linear Wear Rate
Time Frame: 5 Years Post-Surgery
|
Linear wear rate is defined as the annual rate of removal of the polyethylene from the X3 polyethylene insert mated with LFIT™ Anatomic CoCr Femoral Heads determined by comparing digitized images of serial radiographs obtained over the follow-up period. . |
5 Years Post-Surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
Time Frame: preoperative, 1, 3, and 5 years
|
The change in HHS is reported by comparing the mean preoperative, 1, 3, and 5 year scores. The HHS assesses pain, function, joint deformity and range of motion. Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor |
preoperative, 1, 3, and 5 years
|
Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits
Time Frame: preop, 1, 3, and 5 Years
|
This subscore of the overall HHS provides the patient with 6 possible answers to choose from ranging from, no pain/ignores it, to totally disabled/crippled/pain in bed/bedridden. A maximum of 44 points is possible for this subscore indicating no pain/ignores it. Pain:
|
preop, 1, 3, and 5 Years
|
Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.
Time Frame: preoperative, 1, 3, and 5 Years
|
This subscore of the overall HHS includes the total points awarded for five different ranges of motion (flexion, abduction, external rotation, internal rotation, adduction). Subscore range is minimum of 0 to maximum of 5 points; the higher the value, the better the outcome. Flexion: 0-45 degrees x 1.0 index value = max 45 points 45-90 degrees x 0.6 index = max 27 points 90-110 degrees x 0.3 index = max 6 points 110-130 degrees = max 0 points Abduction: 0-15 degrees x 0.8 index = max 12 points 15-20 degrees x 0.3 index = max 1.5 points 20-45 degrees x 0 index = max 0 points External Rotation in extension: 0-15 degrees x 0.4 index = max 6 points Over 15 degrees = max 0 points Internal Rotation in extension: Any = max 0 points Adduction: 0-15 degrees x 0.2 index = max 3 points Over 15 degrees - max 0 points To determine the over-all rating for range of motion, multiply the sum of the index values x 0.05. |
preoperative, 1, 3, and 5 Years
|
Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.
Time Frame: preop, 1, 3, and 5 Years
|
The change in SF-12 is reported by comparing the mean preoperative, 1, 3, and 5 year scores.
The SF-12 Health Survey is a 12 item patient completed questionnaire to measure general health and well-being.
It includes a physical component score and mental status component score; each ranging from 0-100.
Low values represent a poor health state and high values represent a good health state.
|
preop, 1, 3, and 5 Years
|
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
Time Frame: preoperative, 1, 3, and 5 Years
|
The change in LEAS is reported by comparing the mean pre-operative, 1,3,and 5 year scores.
The LEAS completed by the participant to assess activity level.
Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
|
preoperative, 1, 3, and 5 Years
|
Number of Hips That Dislocated
Time Frame: 3 and 5 years
|
The number of hips that experienced a hip dislocation.
|
3 and 5 years
|
Number of Hips Evaluated as Radiographically Unstable
Time Frame: 1, 3, 5 years
|
Radiographic instability is defined as having any of the following findings on x-ray:
|
1, 3, 5 years
|
Percentage of Cases That Did Not Have Any Component Revised
Time Frame: 5 years
|
A revision is defined as surgical removal and replacement of the femoral bearing head or femoral stem components, or the acetabular shell or acetabular polyethylene liner. The 97.42% estimate is obtained by Kaplan-Meier method. |
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 63
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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