NCT01247038

Brief Summary

The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

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

First Submitted

Initial submission to the registry

November 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2015

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

4.5 years

First QC Date

November 22, 2010

Last Update Submit

June 19, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Metal ion concentration in blood and urine

    Metal ion concentration will be determined from patients blood and urine at prescribed intervals

    2 years post operatively

Secondary Outcomes (1)

  • Composite Clinical Score (CCS) rate at 2 years post operative

    2 years post operatively

Study Arms (2)

Metal on ceramic articulation

EXPERIMENTAL

The arm consists of patients with Ceramic femoral heads articulating with metal acetabular cups

Device: Metal on ceramic articulation

Metal-on-metal

ACTIVE COMPARATOR

The arm consists of patients with Metal femoral heads articulating with metal acetabular cups

Device: Metal-on-Metal

Interventions

Metal on ceramic articulationDEVICE

Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup

Also known as: MagnumC
Metal on ceramic articulation
Metal-on-MetalDEVICE

Metal on Metal articulation

Also known as: Magnum
Metal-on-metal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip replacement
  • Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
  • Patients preoperative Harris hip score \< 80 points
  • Patients with limited co-morbidity - ASA I - III
  • Patients with normal urea and electrolyte levels and creatinine levels
  • Patients must be able to understand instructions and be willing to return for follow-up
  • Patients willing to provide blood and urine samples for metal ion analysis at follow-up

You may not qualify if:

  • Patient preoperative Harris hip score \> 80 points
  • Pre-existing metal implants
  • Patients with significant co-morbidity - ASSA IV - V
  • Dementia and inability to understand and follow instructions
  • Neurological conditions affecting movement
  • Women younger than 45 years old
  • Presence of symptomatic arthritis in other lower limb joints
  • Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
  • Patients taking NSAIDs and / all drugs that will affect bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopaedic Hospital & Rehabilitation Clinic of "Dr Miroslav Zotovic"

Banja Luka, Bosnia and Herzegovina

Location

Johannesburg Hospital

Parktown, South Africa

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Metal-on-Metal Joint Prostheses

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Joint ProsthesisProstheses and ImplantsEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 24, 2010

Study Start

January 1, 2011

Primary Completion

July 10, 2015

Study Completion

July 10, 2015

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)BO(1)