Cormet Post-PMA Study: New Enrollment

Rheumatoid Arthritis Clinical Trial

— PASNew  

Official title:

Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722007
• Other study ID #: Cormet (P050016) New Enroll
• Status: Completed
• Phase: N/A
• Start date: April 24, 2008
• Est. completion date: May 12, 2014

Study information

• Verified date: May 2019
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Description:

This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 12, 2014
• Est. primary completion date: April 11, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female patient who meets eligibility criteria consistent with product labeling

• skeletally mature

• mentally capable of completing follow-up forms

• Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation

• Has been deemed a candidate for hip replacement by diagnosis of the investigator

• consented to participate in the clinical study

Exclusion Criteria:

• Patient with active or suspected infection in or around the hip joint;

• Patient with bone stock inadequate to support the device

• Patient with severe osteopenia

• Patient with a family history of severe osteoporosis or severe osteopenia;

• Patient with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade)

• Patient with multiple cysts of the femoral head (>1cm)

• In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.

• Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;

• Female of child-bearing age due to unknown effects on the fetus of metal ion release.

• Patient with known moderate or severe renal insufficiency;

• Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids;

• Patient who is severely overweight;

• Patient with known or suspected metal sensitivity (e.g., jewelry).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Osteonecrosis
• Rheumatoid Arthritis

Intervention

Device:
• Cormet Hip Resurfacing
Cormet Hip Resurfacing implant

Locations

Country	Name	City	State
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Memorial Bone and Joint Clinic	Houston	Texas
United States	Lattimore Orthopaedics P.C.	Rochester	New York
United States	Willamette Orthopedic Group LLC	Salem	Oregon
United States	Florida Orthopaedic Institute	Tampa	Florida
United States	George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24	Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) = 80 points.	Month 24+
Secondary	Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+	All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9)	Month 24+
Secondary	Survival Rate Using Kaplan-Meier Survival Curves	Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24	Month 24+
Secondary	Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events		Month 24+
Secondary	The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively	The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head = 5mm; Retroversion of the Head = 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis	Month 24+