Shoulder OsteoarthritisNCT07060469
Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.
An observational study of Shoulder Osteoarthritis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial summary
This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients who have had a shoulder replacement within the last 10 years anatomic, reverse, or hemi-arthroplasty and who are aged over 70 at the time of surgery will be included.
Who may be able to join
- All genders Over 70 All ethnic groups Anatomic / Reverse / Hemi shoulder replacement
Who cannot join
- Under 70 years of age Shoulder replacement for trauma/tumour
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Analysis of Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty in Patients Over 70: A Retrospective Single Unit Single Surgeon Study
This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.
Read the detailed description
Despite numerous studies, the literature presents conflicting evidence regarding the comparative effectiveness of anatomic shoulder arthroplasty (aTSA) versus reverse shoulder arthroplasty in primary humeral osteoarthritis among patients aged over 70 years.
There is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.
This retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis.
- Conditions
- Shoulder Osteoarthritis
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 |
|---|---|---|
| Anatomic Shoulder Arthroplasty | Type of shoulder replacement | |
| Hemiarthroplasty | Type of shoulder replacement | |
| Reverse Shoulder Arthroplasty | Type of shoulder replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff failure
Information will be retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty. This will indicate the failure rate of these types of shoulder replacement.
Measured: within the last 10 years
Secondary outcomes (1)
Oxford Shoulder Score (OSS)
The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. The lower the score indicates the greatest disability.
Measured: within the last 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mr I Tsolis, Principal investigator, The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060469
- Sponsor's protocol ID
- RL1 905
- Other IDs
- RL1 905
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hao KA, Boschert EN, O'Keefe DS, Saengchote SA, Schoch BS, Wright JO, Wright TW, Farmer KW, Struk AM, King JJ. Comparison of clinical outcomes of revision reverse total shoulder arthroplasty for failed primary anatomic vs. reverse shoulder arthroplasty. JSES Int. 2022 Dec 16;7(2):257-263. doi: 10.1016/j.jseint.2022.11.003. eCollection 2023 Mar.
PubMed 36911771Heifner JJ, Kumar AD, Wagner ER. Glenohumeral osteoarthritis with intact rotator cuff treated with reverse shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2021 Dec;30(12):2895-2903. doi: 10.1016/j.jse.2021.06.010. Epub 2021 Jul 20.
PubMed 34293419Orvets ND, Chan PH, Taylor JM, Prentice HA, Navarro RA, Garcia IA. Similar rates of revision surgery following primary anatomic compared with reverse shoulder arthroplasty in patients aged 70 years or older with glenohumeral osteoarthritis: a cohort study of 3791 patients. J Shoulder Elbow Surg. 2023 Sep;32(9):1893-1900. doi: 10.1016/j.jse.2023.03.021. Epub 2023 Apr 17.
PubMed 37075936Su F, Nuthalapati P, Feeley BT, Lansdown DA. Outcomes of anatomic and reverse total shoulder arthroplasty in patients over the age of 70: a systematic review. JSES Rev Rep Tech. 2023 Mar 4;3(2):181-188. doi: 10.1016/j.xrrt.2023.02.003. eCollection 2023 May.
PubMed 37588441Jensen AR, Tangtiphaiboontana J, Marigi E, Mallett KE, Sperling JW, Sanchez-Sotelo J. Anatomic total shoulder arthroplasty for primary glenohumeral osteoarthritis is associated with excellent outcomes and low revision rates in the elderly. J Shoulder Elbow Surg. 2021 Jul;30(7S):S131-S139. doi: 10.1016/j.jse.2020.11.030. Epub 2021 Jan 20.
PubMed 33484829
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty in Patients Over 70: A Retrospective Single Unit Single Surgeon Study
- ClinicalTrials.gov ID
- NCT07060469
- Acronym / sponsor ID
- RL1 905
- Conditions
- Shoulder Osteoarthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2025 (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.
This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary and Oxford Shoulder Scores as secondary outcome measures.
Detailed description
Despite numerous studies, the literature presents conflicting evidence regarding the comparative effectiveness of anatomic shoulder arthroplasty (aTSA) versus reverse shoulder arthroplasty in primary humeral osteoarthritis among patients aged over 70 years.
There is anecdotal evidence that doing a shoulder replacement in the above 70-year-old patient could potentially lead to early failure and revision due to rotator cuff tears. There is currently a UK run RCT looking into randomising patient above 60 in reverse or anatomic shoulder replacement. Current literature provides inconclusive evidence, and our local practice does not suggest early failure and revision of anatomic shoulder replacement in the over 70s. The aim of the study is to investigate this and provide solid evidence.
This retrospective analysis will utilize a decade of data from a single surgeon's practice, supplemented by information retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty-aged over 70 at the time of surgery will be included. Data will be cross-referenced with local databases for pre- and postoperative Oxford Shoulder Scores (OSS), primary diagnoses, and complications. The study population includes patients with recorded Oxford Shoulder Scores at a minimum of one year and a maximum of seven years postoperatively. IBM SPSS V.25 will be used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anatomic Shoulder Arthroplasty | – | –Type of shoulder replacement |
| Hemiarthroplasty | – | –Type of shoulder replacement |
| Reverse Shoulder Arthroplasty | – | –Type of shoulder replacement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients who have had a shoulder replacement within the last 10 years anatomic, reverse, or hemi-arthroplasty and who are aged over 70 at the time of surgery will be included.
Key inclusion criteria (1 listed)
- All genders Over 70 All ethnic groups Anatomic / Reverse / Hemi shoulder replacement
Key exclusion criteria (1 listed)
- Under 70 years of age Shoulder replacement for trauma/tumour
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
Rotator cuff failure
Time frame: within the last 10 years
Information will be retrieved from the UK National Joint Registry in. Patients that had a shoulder replacement-anatomic, reverse, or hemi-arthroplasty. This will indicate the failure rate of these types of shoulder replacement.
1 secondary outcome
Oxford Shoulder Score (OSS)
Time frame: within the last 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 36911771Hao KA, Boschert EN, O'Keefe DS, Saengchote SA, Schoch BS, Wright JO, Wright TW, Farmer KW, Struk AM, King JJ. Comparison of clinical outcomes of revision reverse total shoulder arthroplasty for failed primary anatomic vs. reverse shoulder arthroplasty. JSES Int. 2022 Dec 16;7(2):257-263. doi: 10.1016/j.jseint.2022.11.003. eCollection 2023 Mar.
- Background: PubMed 34293419Heifner JJ, Kumar AD, Wagner ER. Glenohumeral osteoarthritis with intact rotator cuff treated with reverse shoulder arthroplasty: a systematic review. J Shoulder Elbow Surg. 2021 Dec;30(12):2895-2903. doi: 10.1016/j.jse.2021.06.010. Epub 2021 Jul 20.
- Background: PubMed 37075936Orvets ND, Chan PH, Taylor JM, Prentice HA, Navarro RA, Garcia IA. Similar rates of revision surgery following primary anatomic compared with reverse shoulder arthroplasty in patients aged 70 years or older with glenohumeral osteoarthritis: a cohort study of 3791 patients. J Shoulder Elbow Surg. 2023 Sep;32(9):1893-1900. doi: 10.1016/j.jse.2023.03.021. Epub 2023 Apr 17.
- Background: PubMed 37588441Su F, Nuthalapati P, Feeley BT, Lansdown DA. Outcomes of anatomic and reverse total shoulder arthroplasty in patients over the age of 70: a systematic review. JSES Rev Rep Tech. 2023 Mar 4;3(2):181-188. doi: 10.1016/j.xrrt.2023.02.003. eCollection 2023 May.
- Background: PubMed 33484829Jensen AR, Tangtiphaiboontana J, Marigi E, Mallett KE, Sperling JW, Sanchez-Sotelo J. Anatomic total shoulder arthroplasty for primary glenohumeral osteoarthritis is associated with excellent outcomes and low revision rates in the elderly. J Shoulder Elbow Surg. 2021 Jul;30(7S):S131-S139. doi: 10.1016/j.jse.2020.11.030. Epub 2021 Jan 20.
- 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.
Mr I Tsolis principal investigator
The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Osteoarthritis, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (01691404418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff failure (time frame: within the last 10 years). 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 NCT07060469, which also lists 5 linked publications.
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 11 Jul 2025.