Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)

Large Diameter Metal-on-Metal Total Hip System IDE

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00867256

Enrollment

195

Registered

2009-03-23

Start date

2004-03-31

Completion date

2009-04-27

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis

Keywords

arthritis

Brief summary

To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.

Detailed description

The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.

Interventions

DEVICELarge Diameter Metal on Metal

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patient: * is skeletally mature * is mentally capable of completing follow-up forms * will be available for follow-up out to 2 years * has a preoperative Harris Hip Score \<70 points * has been deemed a candidate for hip replacement by diagnosis of the investigator.

Exclusion criteria

Patient: * has active joint infection * has had previous hip arthrodesis (fusion) * has had above knee amputation of either extremity * has active neoplastic disease * has a need for a structural bone graft in the operative side * has an ipsilateral hemi or total arthroplasty of any kind * has a nonunion or malunion of any part of the femur on operative side * has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph * is a prisoner * is pregnant * is known to be allergic to implant materials * is morbidly obese.

Design outcomes

Primary

Measure	Time frame	Description
Composite clinical criterion	24-months postoperative	Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026