SurvivorshipNCT01308463
Discovery Elbow Long-Term Survivorship
An observational study of Survivorship and Pain, run by Zimmer Biomet at 4 sites in United States.
Trial summary
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Survivorship, Pain
- What is being tested?
- Discovery elbow minimally constrained
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study
Who may be able to join
- Participant in the Discovery Elbow Multi-center Study
- Consent to participate in the Discovery Elbow Long-Term Survivorship Study
Who cannot join
- Patient is not a Discovery Elbow Multi-center Participant
- Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Indiana Hand to Shoulder Center
Indianapolis, Indiana, 46260
Vanderbilt Hand Center
Nashville, Tennessee, 37232
Florida Orthopedic Institute
Tampa, Florida, 33637
About this study
Official title: Discovery Elbow Long-Term Survivorship Study
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.
Read the detailed description
Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.
In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.
- Conditions
- Survivorship, Pain
- Being tested
- Discovery elbow minimally constrained
- Keywords
- elbow long-term Survivorship, Study participant Discovery Elbow Multi-center Study who, consent for the Discovery Elbow Long-term SurvivorshipStudy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discovery elbow minimally constrainedDevice
patient participating in the Discovery Elbow Multi-center study
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
Measured: 10 Years Post-op
Patient Derived American Shoulder and Elbow Society (ASES) Function
This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.
Measured: 10 Years Post-op
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
This is the patient's perception of satisfaction with the elbow replacement surgery.
Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.
Measured: 10 Years Post-op
Secondary outcomes (1)
Survivorship Will be Measured by the Incidence of Revision or Removals
The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed
Measured: 10 years Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Study terminated due to change in sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell Schenck, PhD, Study director, Director Clinical Research, Biomet Orthopedics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308463
- Sponsor's protocol ID
- ORTHO.CR.EX002
- Status last verified
- Mar 2017
- First submitted
- 23 Jul 2010
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery Elbow Long-Term Survivorship Study
- ClinicalTrials.gov ID
- NCT01308463
- Acronym / sponsor ID
- ORTHO.CR.EX002
- Conditions
- Survivorship, Pain
- Keywords
- elbow long-term Survivorship, Study participant Discovery Elbow Multi-center Study who, consent for the Discovery Elbow Long-term SurvivorshipStudy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to change in sponsorship
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.
Detailed description
Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.
In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study
Key inclusion criteria (2 listed)
- Participant in the Discovery Elbow Multi-center Study
- Consent to participate in the Discovery Elbow Long-Term Survivorship Study
Key exclusion criteria (2 listed)
- Patient is not a Discovery Elbow Multi-center Participant
- Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
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 |
|---|---|---|
| Discovery elbow minimally constrainedpatient participating in the Discovery Elbow Multi-center study | Device | – |
Primary outcome
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
Time frame: 10 Years Post-op
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
Patient Derived American Shoulder and Elbow Society (ASES) Function
Time frame: 10 Years Post-op
This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
Time frame: 10 Years Post-op
This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.
1 secondary outcome
Survivorship Will be Measured by the Incidence of Revision or Removals
Time frame: 10 years Post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Russell Schenck, PhD study director
Director Clinical Research, Biomet Orthopedics, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivorship and Pain, run by Zimmer Biomet 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 2 inclusion and 2 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 1 May 2017. 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?
Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score (time frame: 10 Years Post-op). The study lists 3 primary outcomes in all. 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 1 May 2017.