NCT00867256

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2004

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 23, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2009

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

April 7, 2008

Last Update Submit

September 20, 2023

Conditions

OsteoarthritisRheumatoid ArthritisAvascular Necrosis

Keywords

arthritis

Outcome Measures

Primary Outcomes (1)

  • Composite clinical criterion

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

    24-months postoperative

Study Arms (1)

Large Diameter Metal on Metal

EXPERIMENTAL
Device: Large Diameter Metal on Metal

Interventions

Large Diameter Metal on MetalDEVICE
Large Diameter Metal on Metal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidOsteonecrosisArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giulia Carli

    Corin Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2008

First Posted

March 23, 2009

Study Start

March 31, 2004

Primary Completion

October 23, 2006

Study Completion

April 27, 2009

Last Updated

September 22, 2023

Record last verified: 2023-09