Osteoarthritis of the ShoulderNCT01587560
A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
A study testing PyroTITAN, Ascension Orthopedics, Inc. and TITAN, Ascension Orthopedics, Inc. in people with Osteoarthritis of the Shoulder, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- PyroTITAN, Ascension Orthopedics, Inc. and TITAN, Ascension Orthopedics, Inc.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Jan 2018
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or secondary osteoarthritis of the shoulder
- Age 40-75 years
- Patient capable of giving informed consent
- Patient agrees to comply with the study plan
Who cannot join
- Destruction of the proximal humerus
- Insufficient bone stock
- Deficient rotator cuff or earlier failed surgery of the rotator cuff
- Large muscle defects or insufficient blood supply in the affected arm
- Neuromuscular disorders
- Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study
Show all 12Show fewer
- Patient unwilling to comply with study regulations
- Patient with earlier allergic reaction to pyrocarbon
- Patient with known metastatic disease
- Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.
- Patient participating in other clinical study
- Patient in need of glenoid replacement
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic department, Danderyd Hospital
Stockholm, Stockholm County, 18288
About this study
The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- PyroTITAN, Ascension Orthopedics, Inc., TITAN, Ascension Orthopedics, Inc.
- Keywords
- Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyroTITAN, Ascension Orthopedics, Inc.Device
Also called TITAN, Ascension Orthopedics, Inc.
All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.
TITAN, Ascension Orthopedics, Inc.Device
| Study group | Role | What they receive |
|---|---|---|
| Pyrocarbon | Active comparator | Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty) Receives: Device: PyroTITAN, Ascension Orthopedics, Inc.; Device: TITAN, Ascension Orthopedics, Inc. |
| CoCr | Active comparator | Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty) Receives: Device: PyroTITAN, Ascension Orthopedics, Inc.; Device: TITAN, Ascension Orthopedics, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fixation to bone as measured with radiostereometric analysis (RSA)
Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.
Measured: 24 months
Secondary outcomes (1)
Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)
Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.
Measured: 24-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ascension Orthopedics, Inc., Swedish Shoulder and Elbow Arthroplasty Register, Karolinska Institutet
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587560
- Sponsor's protocol ID
- PyroTITAN DS
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2012
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
- ClinicalTrials.gov ID
- NCT01587560
- Acronym / sponsor ID
- PyroTITAN DS
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- Shoulder, Arthroplasty, Pyrocarbon, Randomized controlled trial, Shoulder resurfacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Ascension Orthopedics, Inc., Swedish Shoulder and Elbow Arthroplasty Register, Karolinska Institutet
- Study start
- Jan 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Apr 2012 (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 purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyrocarbon | Active comparator | Device: PyroTITAN, Ascension Orthopedics, Inc., Device: TITAN, Ascension Orthopedics, Inc.Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty) |
| CoCr | Active comparator | Device: PyroTITAN, Ascension Orthopedics, Inc., Device: TITAN, Ascension Orthopedics, Inc.Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary or secondary osteoarthritis of the shoulder
- Age 40-75 years
- Patient capable of giving informed consent
- Patient agrees to comply with the study plan
Key exclusion criteria (12 listed)
- Destruction of the proximal humerus
- Insufficient bone stock
- Deficient rotator cuff or earlier failed surgery of the rotator cuff
- Large muscle defects or insufficient blood supply in the affected arm
- Neuromuscular disorders
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 |
|---|---|---|
| PyroTITAN, Ascension Orthopedics, Inc.Also: TITAN, Ascension Orthopedics, Inc.All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design. | Device | CoCr, Pyrocarbon |
| TITAN, Ascension Orthopedics, Inc. | Device | CoCr, Pyrocarbon |
Primary outcome
Fixation to bone as measured with radiostereometric analysis (RSA)
Time frame: 24 months
Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.
1 secondary outcome
Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)
Time frame: 24-48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PyroTITAN, Ascension Orthopedics, Inc. and TITAN, Ascension Orthopedics, Inc. in people with Osteoarthritis of the Shoulder, run by Danderyd Hospital at 1 site in Sweden.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
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?
Fixation to bone as measured with radiostereometric analysis (RSA) (time frame: 24 months). 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 30 Aug 2016.