OsteoarthritisNCT00698867
A Clinical Investigation of the Discovery™ Elbow System
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC at 4 sites in United States.
Trial summary
The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- How many people
- 118 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2002to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Inflammatory arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Treatment of acute fractures or non-union about the elbow
- Patient Selection factors to be considered include:
Show all 13Show fewer
- Need to obtain pain relief and improve function.
- Ability and willingness to follow instructions including control of weight and activity levels.
- Patients who are able and willing to return for follow-up evaluations.
- Patients with a good nutritional state.
- Patients with full skeletal maturity.
- Patients of all races and gender.
- Patients who are able to follow care instructions.
Who cannot join
- Patients less than 18 years.
- Patients with marked bone loss which would preclude proper fixation of the prosthesis.
- Metabolic disorders, which may impair bone formation.
- Patients who are pregnant.
- Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
- Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc.).
- Patients unwilling or unable to comply with a rehabilitation program for elbow replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
- Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
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: A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
The purpose of this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
Read the detailed description
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
- Keywords
- Total Elbow Arthroplasty, Total Elbow Replacement, Osteoarthritis, Elbow arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis, Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Discovery™ Elbow | Discovery™ Elbow minimally constrained |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Society Score (ASES) Pain Assessment
This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Measured: 5 years
Patient Derived American Shoulder and Elbow Society Score (ASES) Function
This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.
Measured: 5 Years
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction
This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.
Measured: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs
This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.
Measured: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability
Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.
Measured: 5 Years
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength
Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
Measured: 5 Years
Secondary outcomes (1)
Incidence of Surviving Elbows
Proportion of elbows that did not require revision or removal
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2002
- Primary completionJul 2016
- Study completionJul 2016
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 OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomet Orthopedics, LLC
- 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
- NCT00698867
- Sponsor's protocol ID
- ORTHO.CR.EX001
- Status last verified
- Apr 2017
- First submitted
- 13 Jun 2008
- Last updated
- 7 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-controlled, Clinical Investigation of the Discovery™ Elbow System
- ClinicalTrials.gov ID
- NCT00698867
- Acronym / sponsor ID
- ORTHO.CR.EX001
- Keywords
- Total Elbow Arthroplasty, Total Elbow Replacement, Osteoarthritis, Elbow arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Biomet Orthopedics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 7 Aug 2017
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 this study is to perform a five-year, multi-center prospective evaluation of the Discovery™ Elbow System for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.
Detailed description
Patient follow-up outcomes measured by the ASES score, radiographs and adverse events/revisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discovery™ Elbow | – | –Discovery™ Elbow minimally constrained |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in need of relief from painful or disabling Joint Disease in need of total elbow replacment.
Key inclusion criteria (13 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Inflammatory arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Treatment of acute fractures or non-union about the elbow
Key exclusion criteria (8 listed)
- Patients less than 18 years.
- Patients with marked bone loss which would preclude proper fixation of the prosthesis.
- Metabolic disorders, which may impair bone formation.
- Patients who are pregnant.
- Patients with an active or suspected infection in or around the elbow or distant foci of infections, which may spread to the implant site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
American Shoulder and Elbow Society Score (ASES) Pain Assessment
Time frame: 5 years
This is a patient reported outcome measure that indicates the patient's pain as measured on the ASES form. The maximum pain score is 50 and the minimum score is 0. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Patient Derived American Shoulder and Elbow Society Score (ASES) Function
Time frame: 5 Years
This is a measure of patient function as answered by the patient. The maximum score is 36 and the minimum is 0. The maximum score represents maximum function.
Patient Derived American Shoulder and Elbow Society Score (ASES) Satisfaction
Time frame: 5 Years
This is a measure of patient satisfaction as answered by the patient. The maximum score is 10 and the minimum is 0. The maximum score indicates maximum satisfaction.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Signs
Time frame: 5 Years
This is a measure of the elbow signs as reported by the investigator. Signs include various assessments of joint tenderness, impingement, and pain in range of motion. The maximum score is 39 and the minimum is 0. The maximum score indicates the most abnormal signs.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Stability
Time frame: 5 Years
Surgeon assessment of patient elbow stability. Maximum instability score is 9 and the minimum is 0. The maximum score indicates the least stability.
Surgeon Derived American Shoulder and Elbow Society Score (ASES) Strength
Time frame: 5 Years
Measure of elbow strength as defined by the investigator. Maximum score is 20 and the minimum is 0. The maximum score indicates maximum strength.
1 secondary outcome
Incidence of Surviving Elbows
Time frame: Up to 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Osteoarthritis and Rheumatoid Arthritis, run by Biomet Orthopedics, LLC 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 13 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: finished, as of the sponsor's last update on 7 Aug 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 7 Aug 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?
American Shoulder and Elbow Society Score (ASES) Pain Assessment (time frame: 5 years). The study lists 6 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 7 Aug 2017.