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

Rheumatoid Arthritis Clinical Trial

Official title:

Large Diameter Metal-on-Metal Total Hip System IDE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00867256
• Other study ID #: LDMOM
• Status: Terminated
• Phase: N/A
• Start date: March 31, 2004
• Est. completion date: April 27, 2009

Study information

• Verified date: September 2023
• Source: Corin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 195
• Est. completion date: April 27, 2009
• Est. primary completion date: October 23, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Large Diameter Metal on Metal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Outcome

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