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TerminatedNCT00867256Updated Sep 22, 2023

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

An interventional study of Large Diameter Metal on Metal in Osteoarthritis, Rheumatoid Arthritis and Avascular Necrosis, sponsored by Corin. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-22.

Sponsored by Corin · Not applicable, Interventional, and Treatment

Why this study was terminated
terminated for business reasons; study closed.

From the registry’s dates

  • Primary completion was Oct 2006, 19 years 11 months ago, and no results have been posted to the registry.
  • Registered 4 years after the study started (first participant enrolled Mar 2004, registered Apr 2008).
Phase
Not applicable
Study type
Interventional
Enrollment
195
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis
  • Rheumatoid Arthritis
  • Avascular Necrosis

Keywords

  • arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 195 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Corin is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
195 participants (actual)

Study arms

  • Experimental
    Large Diameter Metal on Metal

    Device: Large Diameter Metal on Metal

Interventions

  • DeviceLarge Diameter Metal on Metal
06

What researchers measure

Primary outcomes

  1. Composite clinical criterion

    Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component

    Time frame: 24-months postoperative

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00867256
Lead sponsor
Corin
Responsible party
Sponsor
First posted
Mar 23, 2009
Start date
Mar 31, 2004
Primary completion
Oct 23, 2006
Completion
Apr 27, 2009
Last update
Sep 22, 2023

Study contacts

Giulia Carli
study director · Corin Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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