Shoulder OsteoarthritisNCT03922763
Fixed Inclination Humeral Cut
A study testing Anatomical cut and Cutting guide in people with Shoulder Osteoarthritis, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- Anatomical cut and Cutting guide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2019to 2 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients 18 years or older
- primary glenohumeral osteoarthritis
- intact rotator cuff
- primary anatomic shoulder arthroplasty
Who cannot join
- revision arthroplasty
- reverse shoulder arthroplasty candidates
- cognitive or behavioral problems which would preclude informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial
The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.
- Conditions
- Shoulder Osteoarthritis
- Being tested
- Anatomical cut, Cutting guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical cutProcedure or surgery
Surgeon-derived cut based on patient's anatomy
Cutting guideProcedure or surgery
Angle cut at 132.5 degrees based on cutting guide
| Study group | Role | What they receive |
|---|---|---|
| Anatomically-matched cut | Active comparator | Not described Receives: Procedure: Anatomical cut |
| Cutting guide | Active comparator | Not described Receives: Procedure: Cutting guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radriographic measurements
x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement
Measured: x-rays taken day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start2 Feb 2019
- Primary completion2 Feb 2020 (estimated)
- Study completion2 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922763
- Sponsor's protocol ID
- 2019Laz
- Status last verified
- Apr 2019
- First submitted
- 17 Apr 2019
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03922763
- Acronym / sponsor ID
- 2019Laz
- Conditions
- Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 2 Feb 2020 (estimated)
- Study completion
- 2 May 2020 (estimated)
- First posted
- 22 Apr 2019 (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 purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomically-matched cut | Active comparator | Procedure: Anatomical cut |
| Cutting guide | Active comparator | Procedure: Cutting guide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients 18 years or older
- primary glenohumeral osteoarthritis
- intact rotator cuff
- primary anatomic shoulder arthroplasty
Key exclusion criteria (3 listed)
- revision arthroplasty
- reverse shoulder arthroplasty candidates
- cognitive or behavioral problems which would preclude informed consent
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 |
|---|---|---|
| Anatomical cutSurgeon-derived cut based on patient's anatomy | Procedure or surgery | Anatomically-matched cut |
| Cutting guideAngle cut at 132.5 degrees based on cutting guide | Procedure or surgery | Cutting guide |
Primary outcome
Radriographic measurements
Time frame: x-rays taken day of surgery
x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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 Anatomical cut and Cutting guide in people with Shoulder Osteoarthritis, run by Rothman Institute Orthopaedics 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 4 inclusion and 3 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 22 Apr 2019. 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?
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?
Radriographic measurements (time frame: x-rays taken day of surgery). 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 22 Apr 2019.