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

September 20, 2023 updated by: Corin

Large Diameter Metal-on-Metal Total Hip System IDE

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Large Diameter Metal on Metal
Device: Large Diameter Metal on Metal

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corin

Investigators

  • Study Director: Giulia Carli, Corin Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2004

Primary Completion (Actual)

October 23, 2006

Study Completion (Actual)

April 27, 2009

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

March 19, 2009

First Posted (Estimated)

March 23, 2009

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDMOM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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