Osteoarthritis ShoulderHRPNCT05615246
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
An observational study of Osteoarthritis Shoulder and Rheumatoid Arthritis, run by Exactech at 1 site in United States.
Trial summary
The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2018to 25 Sep 2024
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Patients who meet eligibility criteria * Patients who consent to participate to return for follow-up visits out to 10 years or longer
Who may be able to join
- Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
- Patient is at least 21 years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre- and postoperative visit requirements
- Patient is willing and able to read and sign a study informed consent form
Who cannot join
- Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
- Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- Neuromuscular disorders that do not allow control of the joint
- SIgnigicant injury to the brachial plexus
- Non-functional deltoid muscles
- Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system
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- The patient is unwilling or unable to comply with the post-operative care instructions
- Alcohol, drug, or other subtance abuse
- Any disease state that could adversely affect the function or longevity of the implant
- Patient is pregnant
- Patient is a prisoner
- Patient has a physical or mental condition that would invalidate the results
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Orthopaedics Research and Education Foundation
Denver, Colorado, 80218
About this study
Official title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology
- Medical subject headings
- Arthritis, Rheumatoid, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
SST-12
Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%
Measured: Through study completion, an average of 1 per year
SPADI
Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities
Measured: Through study completion, an average of 1 per year
Constant
Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
Measured: Through study completion, an average of 1 per year
ASES
American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
Measured: Through study completion, an average of 1 per year
UCLA
University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes
Measured: Through study completion, an average of 1 per year
TESS
Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
Measured: Through study completion, an average of 1 per year
MSTS
Musculoskeletal Tumor Society (MSTS) - 30 points [6 times (range 0-5)], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score
Measured: Through study completion, an average of 1 per year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start5 Sep 2018
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Why it stopped: Site closeout
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies of the same condition, open and under way.
- More trials run by ExactechThe 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
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615246
- Sponsor's protocol ID
- CR18-001
- Acronym
- HRP
- Status last verified
- Jan 2025
- First submitted
- 7 Nov 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT05615246
- Acronym / sponsor ID
- HRP / CR18-001
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site closeout
- Enrolment
- 4 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 14 Nov 2022 (actual)
- 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 objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over time. This study will follow subjects for a period of up to 10 years post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients who meet eligibility criteria * Patients who consent to participate to return for follow-up visits out to 10 years or longer
Key inclusion criteria (5 listed)
- Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)
- Patient is at least 21 years of age
- Patient is expected to survive at least 2 years beyond surgery
- Patient is willing to participate by complying with pre- and postoperative visit requirements
- Patient is willing and able to read and sign a study informed consent form
Key exclusion criteria (12 listed)
- Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implentation should be delayed until infection is resolved
- Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
- Neuromuscular disorders that do not allow control of the joint
- SIgnigicant injury to the brachial plexus
- Non-functional deltoid muscles
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
SST-12
Time frame: Through study completion, an average of 1 per year
Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%
SPADI
Time frame: Through study completion, an average of 1 per year
Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities
Constant
Time frame: Through study completion, an average of 1 per year
Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain
ASES
Time frame: Through study completion, an average of 1 per year
American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition
UCLA
Time frame: Through study completion, an average of 1 per year
University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes
TESS
Time frame: Through study completion, an average of 1 per year
Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome
MSTS
Time frame: Through study completion, an average of 1 per year
Musculoskeletal Tumor Society (MSTS) - 30 points [6 times (range 0-5)], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score
Results and safety
The study was stopped early (reason given: Site closeout). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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?
An observational study of Osteoarthritis Shoulder and Rheumatoid Arthritis, run by Exactech at 1 site 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 5 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: stopped early, as of the sponsor's last update on 27 Jan 2025. 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 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: Site closeout). 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?
SST-12 (time frame: Through study completion, an average of 1 per year). The study lists 7 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 27 Jan 2025.