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

Corin logo

Corin

Status

Terminated

Conditions

Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis

Treatments

Device: Large Diameter Metal on Metal

Study type

Interventional

Funder types

Industry

Identifiers

NCT00867256
LDMOM

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

195 participants in 1 patient group

Large Diameter Metal on Metal
Experimental group
Treatment:
Device: Large Diameter Metal on Metal

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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