Clinical trial NCT02405234: Ascension PyroCarbon Radial Head Study
Official title: Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Arthritis
Radial Head Fracture
Rheumatoid Arthritis
Keywords: Radial Head Arthroplasty
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This investigation will include 179 patients (119 study devices and 60 control devices) enrolled at 15 active centers. In addition a subset of 24 RA patients will be enrolled and analyzed separately. The trial is designed as a randomized, non-inferiority study comparing results of the CMRH to results of the MRH.

This will be a multi-site study with all patients either receiving the CMRH or the MRH. Sequential enrollment of all patients meeting inclusion criteria and agreeing to be in the study will be enrolled. The patients will sign an informed consent agreeing to accept either the investigational or control device. In addition, the surgeon will not know which device the patient is to receive until the day of surgery in an attempt to further reduce bias. The surgeon will open an envelope at the time of surgery to determine if a CMRH or MRH will be implanted.

Additional efforts to eliminate bias in the study will include a final radiographic analysis by an independent observer experienced in reporting on orthopedic devices. The independent reviewer will grade the surgical implant and determine radiographic success/failure for each patient.

Implants will be assigned to patients at the clinical sites in a block randomization fashion. The randomization will be site specific. At a given site, each consecutive block of six enrolled patients to be treated will receive random assignments of CMRH or MRH at a 2:1. The randomization schedule is generated by computer (NQuery) and is produced in blocks of 6, where 4 are study devices and 2 are control devices.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Orthopedic and Rehabilitation
state: Florida
city: Dayton
country: United States
facility: Hand Center of Southwestern Ohio
state: Ohio
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Houston
country: United States
facility: Texas Orthopedic Hospital
state: Texas
Study officials:
affiliation: Integra Life Sciences
name: Andrew Tummon
role: STUDY_DIRECTOR
References: