NCT02405234

Brief Summary

The proportion of patient successes with the Carbon Modular Radial Head at the 2-year evaluation is no lower than the proportion of patient successes with the Metal Radial Head.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2017

Enrollment Period

6.2 years

First QC Date

November 4, 2014

Last Update Submit

August 9, 2022

Conditions

Degenerative ArthritisRadial Head FractureRheumatoid Arthritis

Keywords

Radial Head Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival

    2 years

Study Arms (2)

Carbon Modular Radial Head

EXPERIMENTAL

PyroCarbon Modular Radial Head replacement

Device: Carbon Modular Radial Head replacement

Metal Radial Head

ACTIVE COMPARATOR

Metal Radial Head replacement

Device: Metal Radial Head replacement

Interventions

Carbon Modular Radial Head replacementDEVICE

'Carbon Modular Radial Head replacement: The Ascension Radial Head is made of pyrocarbon, a material that testing has shown to be both wear resistant and biocompatible and has been used in surgical implants for years. The introduction of the pyrocarbon head should alleviate the problems associated with wear debris and fragmentation experienced with the silicone radial spacer.

Also known as: Ascension CMRH
Carbon Modular Radial Head
Metal Radial Head replacementDEVICE

Metal Radial Head replacement:The Ascension® Modular Radial Head (MRH) is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. FDA cleared this device for commercial distribution under 510(k) K032686. It is made from medical grade cobalt chromium alloy meeting ASTM F1537. Head components are available in six sizes and stem components are available in four sizes are interchangeable and assembled with a taper connection.

Also known as: Ascension MRH
Metal Radial Head

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must need a radial head replacement for:
  • Degenerative, post-traumatic or rheumatoid arthritis
  • Primary replacement after fracture of the radial head
  • Relief of symptoms after radial head resection
  • Revision of failed radial head arthroplasty
  • Skeletally mature individuals ages 18 - 85

You may not qualify if:

  • Inadequate bone stock or soft tissue coverage
  • Previous open fracture or infection in the joint
  • Individuals under age of 18 or over 85 years of age
  • Physical interference with or by other prostheses during implantation or use
  • Procedures requiring modification of the prosthesis
  • Skin, bone, circulatory and/or neurological deficiency at the implantation site
  • Prisoners
  • Patients on chronic corticosteroid or non-steroidal anti-inflammatory therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Florida Orthopedic and Rehabilitation

Gainesville, Florida, 32611, United States

Location

Hand Center of Southwestern Ohio

Dayton, Ohio, 45405, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Orthopedic Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

OsteoarthritisRadial Head and Neck FracturesArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesElbow FracturesElbow InjuriesArm InjuriesWounds and InjuriesRadius FracturesForearm InjuriesFractures, BoneConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Andrew Tummon

    Integra Life Sciences

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 4, 2014

First Posted

April 1, 2015

Study Start

January 1, 2009

Primary Completion

March 1, 2015

Study Completion

January 1, 2017

Last Updated

August 11, 2022

Record last verified: 2017-08

Locations

US(4)