Degenerative ArthritisCMRHNCT02405234
Ascension PyroCarbon Radial Head Study
A study testing Carbon Modular Radial Head replacement and Metal Radial Head replacement in people with Degenerative Arthritis and Radial Head Fracture, run by Smith & Nephew, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Degenerative Arthritis, Radial Head Fracture, Rheumatoid Arthritis
- What is being tested?
- Carbon Modular Radial Head replacement and Metal Radial Head replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2009to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hand Center of Southwestern Ohio
Dayton, Ohio, 45405
University of Florida Orthopedic and Rehabilitation
Gainesville, Florida, 32611
Texas Orthopedic Hospital
Houston, Texas, 77030
The Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Being tested
- Carbon Modular Radial Head replacement, Metal Radial Head replacement
- Keywords
- Radial Head Arthroplasty
- Medical subject headings
- Osteoarthritis, Radial Head and Neck Fractures, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Modular Radial Head replacementDevice
Also called Ascension CMRH
'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.
Metal Radial Head replacementDevice
Also called Ascension MRH
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.
| Study group | Role | What they receive |
|---|---|---|
| Carbon Modular Radial Head | Experimental | PyroCarbon Modular Radial Head replacement Receives: Device: Carbon Modular Radial Head replacement |
| Metal Radial Head | Active comparator | Metal Radial Head replacement Receives: Device: Metal Radial Head replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJan 2009
- Primary completionMar 2015
- Study completionJan 2017
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tummon, Study director, Integra Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405234
- Sponsor's protocol ID
- CP-RH-002
- Acronym
- CMRH
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2014
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Study of Ascension PyroCarbon Radial Head Compared to Ascension Metal Radial Head
- ClinicalTrials.gov ID
- NCT02405234
- Acronym / sponsor ID
- CMRH / CP-RH-002
- Keywords
- Radial Head Arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbon Modular Radial Head | Experimental | Device: Carbon Modular Radial Head replacementPyroCarbon Modular Radial Head replacement |
| Metal Radial Head | Active comparator | Device: Metal Radial Head replacementMetal Radial Head replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must need a radial head replacement for:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon Modular Radial Head replacementAlso: Ascension CMRH'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. | Device | Carbon Modular Radial Head |
| Metal Radial Head replacementAlso: Ascension MRHMetal 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. | Device | Metal Radial Head |
Primary outcome
The proportion of patient successes with the Carbon Modular Radial Head vs patient successes with the Metal Radial Head as assessed by implant survival
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Tummon study director
Integra Life Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Modular Radial Head replacement and Metal Radial Head replacement in people with Degenerative Arthritis and Radial Head Fracture, run by Smith & Nephew, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.