Rotator Cuff Tear ArthropathyNCT04093804
Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
A study testing Glenosphere size for Reverse Shoulder Arthroplasty in people with Rotator Cuff Tear Arthropathy and Massive Irreparable Rotator Cuff Tear, run by Fondren Orthopedic Group L.L.P. at 1 site in United States.
Trial summary
The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rotator Cuff Tear Arthropathy, Massive Irreparable Rotator Cuff Tear
- What is being tested?
- Glenosphere size for Reverse Shoulder Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 1 Sep 2024
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty
- No history of prior shoulder arthroplasty
- Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)
- Ability to speak, read and write English
Who cannot join
- Male sex
- Any impairment that would prevent answering the surveys
- No children or adolescents under the age of 18 years old
- No prisoners, pregnant women, or mentally disabled persons
- No Workers' Compensation cases
Trial locations and contacts
1 site in 1 country.
United States1 site
Fondren Orthopedic Group, L.L.P.
Houston, Texas, 77030
About this study
The purpose of this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.
Read the detailed description
A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.
- Being tested
- Glenosphere size for Reverse Shoulder Arthroplasty
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenosphere size for Reverse Shoulder ArthroplastyDevice
Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.
| Study group | Role | What they receive |
|---|---|---|
| 32mm Glenosphere | Active comparator | The control group will receive the standard 32mm glenosphere. Receives: Device: Glenosphere size for Reverse Shoulder Arthroplasty |
| 36mm Glenosphere | Experimental | The experimental group will receive a 36mm glenosphere. Receives: Device: Glenosphere size for Reverse Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
Measured: Change from baseline (pre-operative) to 2 years follow-up
Passive range of motion
Shoulder elevation and external rotation
Measured: Change from baseline (pre-operative) to 2 years follow-up
Secondary outcomes (2)
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Measured: Change from baseline (pre-operative) to 2 years follow-up
Constant-Murley Shoulder Outcome score
Standard functional outcomes questionnaire following shoulder surgery, range 0 - 100 (highest function)
Measured: Change from baseline (pre-operative) to 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Model description
- This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondren Orthopedic Group L.L.P.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093804
- Sponsor's protocol ID
- TOH183
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg. 2016 May;25(5):763-71. doi: 10.1016/j.jse.2015.10.027. Epub 2016 Feb 4.
PubMed 26853756
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glenosphere Size on Range of Motion in Female Patients Undergoing Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04093804
- Acronym / sponsor ID
- TOH183
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondren Orthopedic Group L.L.P.University, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Sep 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 this study is to perform a prospective randomized trial among female patients undergoing reverse shoulder arthroplasty (RSA) to determine if a larger glenosphere allows greater range of motion without an impact on complications.
Detailed description
A current research debate is whether glenosphere size has a significant clinical impact on a patient's range of motion (ROM) following RSA. Some researchers have shown an association between increased glenosphere size and improved ROM, but no study has determined the absolute minimal motion differences that would be recognizable or beneficial by patients. This is mostly attributable to limitations such as small sample sizes as well as the fact that shoulder dynamics are multifactorial in nature. Most studies have shown an increased ROM with larger glenosphere sizes.1 Because smaller patients are often times female and receive smaller implants, female patients may be more susceptible to limited ROM. The purpose of this study is to determine if a larger glenosphere allows for greater ROM in female patients undergoing RSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a randomized trial consisting of female patients undergoing reverse shoulder arthroplasty for rotator cuff tear arthropathy or a massive irreparable rotator cuff tear. The experimental group will receive a 36mm glenosphere and the control group will receive the standard 32mm glenosphere. All other conditions of the surgical procedure will be identical as well as the clinical follow-up.
| Arm | Type | Receives |
|---|---|---|
| 32mm Glenosphere | Active comparator | Device: Glenosphere size for Reverse Shoulder ArthroplastyThe control group will receive the standard 32mm glenosphere. |
| 36mm Glenosphere | Experimental | Device: Glenosphere size for Reverse Shoulder ArthroplastyThe experimental group will receive a 36mm glenosphere. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female sex
- Diagnosis of rotator cuff tear arthropathy or a massive irreparable rotator cuff tear for which the patient has elected to undergo reverse shoulder arthroplasty
- No history of prior shoulder arthroplasty
- Consent to study participation by signing the informed consent and the Protected Health Information (PHI) form (Attachment B and C)
- Ability to speak, read and write English
Key exclusion criteria (5 listed)
- Male sex
- Any impairment that would prevent answering the surveys
- No children or adolescents under the age of 18 years old
- No prisoners, pregnant women, or mentally disabled persons
- No Workers' Compensation cases
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 |
|---|---|---|
| Glenosphere size for Reverse Shoulder ArthroplastyTwo randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups. | Device | 32mm Glenosphere, 36mm Glenosphere |
Primary outcome
Active range of motion
Time frame: Change from baseline (pre-operative) to 2 years follow-up
Shoulder elevation, abduction, external rotation in abduction, and internal rotation
Passive range of motion
Time frame: Change from baseline (pre-operative) to 2 years follow-up
Shoulder elevation and external rotation
2 secondary outcomes
American Shoulder and Elbow Surgeon (ASES) Shoulder Index
Time frame: Change from baseline (pre-operative) to 2 years follow-up
Constant-Murley Shoulder Outcome score
Time frame: Change from baseline (pre-operative) to 2 years follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Background: PubMed 26853756Mollon B, Mahure SA, Roche CP, Zuckerman JD. Impact of glenosphere size on clinical outcomes after reverse total shoulder arthroplasty: an analysis of 297 shoulders. J Shoulder Elbow Surg. 2016 May;25(5):763-71. doi: 10.1016/j.jse.2015.10.027. Epub 2016 Feb 4.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glenosphere size for Reverse Shoulder Arthroplasty in people with Rotator Cuff Tear Arthropathy and Massive Irreparable Rotator Cuff Tear, run by Fondren Orthopedic Group L.L.P. 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 5 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 18 Sep 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?
Contact Mitzi S Laughlin, PhD (713-794-3408, Mitzi.Laughlin@fondren.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion (time frame: Change from baseline (pre-operative) to 2 years follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04093804, which also lists 1 linked publication.
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 18 Sep 2019.