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

Arthroplasty, Replacement, Hip Clinical Trial

— LFIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510458
• Other study ID #: 63
• Status: Completed
• Phase: N/A
• First received: August 1, 2007
• Last updated: February 22, 2018
• Start date: April 2007
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• LFIT™ Femoral Heads With X3® Insert
LFIT™ Anatomic CoCr Femoral Heads With X3® Polyethylene Insert in total hip replacement

Locations

Country	Name	City	State
United States	The Center: Orthopedic & Neurosurgical Care & Research	Bend	Oregon
United States	Tufts Medical Center	Boston	Massachusetts
United States	Cedars Medical Center University of Miami	Miami	Florida
United States	Greater Pittsburgh Orthopaedic Associates	Moon	Pennsylvania
United States	Seaview Orthopedics	Ocean City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linear Wear Rate	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	Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits	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
Secondary	Change in Harris Hip Score (HHS) Pain Score From Pre-operative to Post-operative Visits	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: None or ignores it = 44 points; Slight, occasional, no compromise in activities = 40 points; Mild pain, no effect on average activities, rarely moderate pain with unusual activity, may take aspirin = 30 points; Moderate pain, tolerable but makes concessions to pain. Some limitation of ordinary activity or work. May require occasional pain medicine stronger than aspirin = 20 points; Marked pain, serious limitation of activities = 10 points; Totally disabled, crippled, pain in bed, bedridden = 0 points	preop, 1, 3, and 5 Years
Secondary	Change in Harris Hip Score (HHS) Range of Motion (ROM) Score From Pre-operative to Post-operative Visits.	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
Secondary	Change in SF-12 Health Survey Score (Physical and Mental) From Pre-operative to Post-operative Intervals.	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
Secondary	Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative	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
Secondary	Number of Hips That Dislocated	The number of hips that experienced a hip dislocation.	3 and 5 years
Secondary	Number of Hips Evaluated as Radiographically Unstable	Radiographic instability is defined as having any of the following findings on x-ray: Radiographic indication of progressive radiolucent lines = 2 mm in thickness around the entire acetabular component; Radiographic indication of migration of = 3 mm or = 5° of the acetabular component; Radiographic indication of progressive radiolucent lines = 2 mm thickness around the entire femoral component; Radiographic indication of progressive subsidence of the femoral component of = 5 mm.	1, 3, 5 years
Secondary	Percentage of Cases That Did Not Have Any Component Revised	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