Ascension PyroCarbon Radial Head Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | January 2009 |
| End Date: | March 2018 |
Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
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.
evaluation is no lower than the proportion of patient successes with the Metal Radial Head.
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.
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.
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
We found this trial at
4
sites
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