Cormet Post-PMA Study: New Enrollment

NCT00722007 | Completed Results DMC

• 1 other identifier: Cormet (P050016) New Enroll
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Keywords

hip resurfacing; osteoarthritis; avascular necrosis; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+

  Month 24+

• Survival Rate Using Kaplan-Meier Survival Curves

  Month 24+

• Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events

  Month 24+

• The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively

  Month 24+

Study Arms (1)

Cormet Hip Resurfacing Post-PMA Group

EXPERIMENTAL

hip resurfacing

Device: Cormet Hip Resurfacing

Interventions

Cormet Hip Resurfacing DEVICE

Cormet Hip Resurfacing implant

Also known as: Corin Cormet

Cormet Hip Resurfacing Post-PMA Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Corin: lead

Study Sites (6)

George Washington University

Washington D.C., District of Columbia, 20006, United States

Location

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Lattimore Orthopaedics P.C.

Rochester, New York, 14620, United States

Location

Willamette Orthopedic Group LLC

Salem, Oregon, 97301, United States

Location

Memorial Bone and Joint Clinic

Houston, Texas, 77043, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Lucinda Gerber
• Organization: Corin USA Limited

lucinda.gerber@coringroup.com

(772) 321 2478

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: April 24, 2008
• Primary Completion: April 11, 2014
• Study Completion: May 12, 2014
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-05

Locations

US (6)