Osteoarthritis of the ShoulderNCT06897124
Patients Experiences of Rehabilitation Before and After Reverse Shoulder Arthroplasty
An observational study of Osteoarthritis of the Shoulder, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Reverse shoulder arthroplasty is a complex surgical procedure requiring thorough rehabilitation, and its frequency is increasing globally. While previous studies have quantitatively examined postoperative outcomes, such as pain levels and shoulder function, no research has yet explored patients' subjective experiences… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of the Shoulder
- How many people
- 15 participants
- Where
- 1 siteSweden
- Study dates
- 21 Apr 2022to 23 Oct 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had undergone surgery with a reverse shoulder prosthesis during the period from September to November 2021. Based on background variables from the surgery lists, a strategic selection of participants was made to achieve variation in terms of gender, age, and geographic area.
Who may be able to join
- The inclusion criteria encompassed patients who had undergone elective surgery involving reverse shoulder arthroplasty in the Västra Götaland region who demonstrated proficiency in both spoken and written Swedish.
Who cannot join
- Exclusion criteria applied to cases where the study leader had served as the patient's physiotherapist, the presence of neurological disorders, or the occurrence of surgical complications, such as infection or fracture.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden
Alingsås, Västra Götaland County, 441 60
About this study
Official title: Patients Experiences of Rehabilitation After Reverse Shoulder Arthroplasty - a Qualitative Interview Study
Reverse shoulder arthroplasty is a complex surgical procedure requiring thorough rehabilitation, and its frequency is increasing globally. While previous studies have quantitatively examined postoperative outcomes, such as pain levels and shoulder function, no research has yet explored patients' subjective experiences of the rehabilitation process before and after surgery. Purpose of the study was to explore patients' experiences of undergoing reverse shoulder arthroplasty and the associated rehabilitation process.
Read the detailed description
Surgery with total shoulder arthroplasty is a procedure that has increased in number in the last twenty years, and it is the third most common prosthetic surgery in the world after hip and knee. There are two types of shoulder arthroplasty, anatomical and reverse. When the rotator cuff is severely impaired or completely dysfunctional, a reverse shoulder prosthesis is used, in which the anatomical positions of the ball and socket are reversed.
There are thus several factors that the treating physiotherapist needs to take into account. Research on reverse shoulder arthroplasty has primarily focused on evaluations using quantitative measures. Qualitative research from the patient's perspective can provide a deeper understanding of their expectations and experiences, offering insights that complement and fill the gaps left by quantitative research. Gaining insight into patients' experiences would be valuable for physiotherapists working with this group, as it may help identify areas for improvement in care to better meet patients' needs.
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- Reverse shoulder arthroplasty, qualitative research, physiotherapy, experiences
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 |
|---|---|---|
| Women and men, who had undergone surgery with reverse shoulder arthroplasty. | The participants were recruited from three different hospitals in Western Sweden: a local hospital, a county hospital, and a university hospital. The inclusion criteria encompassed patients who had undergone elective surgery involving reverse shoulder arthroplasty in the Västra Götaland region who demonstrated proficiency in both spoken and written Swedish. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' experiences of undergoing surgery and rehabilitation with reverse shoulder arthroplasty.
Qualitative semi structured individual in-depth interviews were analysed using qualitative content analysis. Fifteen persons, women and men, who had undergone surgery with reverse shoulder arthroplasty between six to twelve months previously, were recruited to the study.
Measured: From time of surgery to end of rehabilitation, approximately 0-7,8 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start21 Apr 2022
- Primary completion23 Oct 2022
- Study completion23 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anette Larsson, RPT, PhD, Study chair, Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897124
- Sponsor's protocol ID
- VGFOUSA-1020701
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Experiences of Rehabilitation After Reverse Shoulder Arthroplasty - a Qualitative Interview Study
- ClinicalTrials.gov ID
- NCT06897124
- Acronym / sponsor ID
- VGFOUSA-1020701
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- Reverse shoulder arthroplasty, qualitative research, physiotherapy, experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 23 Oct 2022 (actual)
- Study completion
- 23 Oct 2022 (actual)
- First posted
- 26 Mar 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.
Reverse shoulder arthroplasty is a complex surgical procedure requiring thorough rehabilitation, and its frequency is increasing globally. While previous studies have quantitatively examined postoperative outcomes, such as pain levels and shoulder function, no research has yet explored patients' subjective experiences of the rehabilitation process before and after surgery. Purpose of the study was to explore patients' experiences of undergoing reverse shoulder arthroplasty and the associated rehabilitation process.
Detailed description
Surgery with total shoulder arthroplasty is a procedure that has increased in number in the last twenty years, and it is the third most common prosthetic surgery in the world after hip and knee. There are two types of shoulder arthroplasty, anatomical and reverse. When the rotator cuff is severely impaired or completely dysfunctional, a reverse shoulder prosthesis is used, in which the anatomical positions of the ball and socket are reversed.
There are thus several factors that the treating physiotherapist needs to take into account. Research on reverse shoulder arthroplasty has primarily focused on evaluations using quantitative measures. Qualitative research from the patient's perspective can provide a deeper understanding of their expectations and experiences, offering insights that complement and fill the gaps left by quantitative research. Gaining insight into patients' experiences would be valuable for physiotherapists working with this group, as it may help identify areas for improvement in care to better meet patients' needs.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women and men, who had undergone surgery with reverse shoulder arthroplasty. | – | –The participants were recruited from three different hospitals in Western Sweden: a local hospital, a county hospital, and a university hospital. The inclusion criteria encompassed patients who had undergone elective surgery involving reverse shoulder arthroplasty in the Västra Götaland region who demonstrated proficiency in both spoken and written Swedish. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had undergone surgery with a reverse shoulder prosthesis during the period from September to November 2021. Based on background variables from the surgery lists, a strategic selection of participants was made to achieve variation in terms of gender, age, and geographic area.
Key inclusion criteria (1 listed)
- The inclusion criteria encompassed patients who had undergone elective surgery involving reverse shoulder arthroplasty in the Västra Götaland region who demonstrated proficiency in both spoken and written Swedish.
Key exclusion criteria (1 listed)
- Exclusion criteria applied to cases where the study leader had served as the patient's physiotherapist, the presence of neurological disorders, or the occurrence of surgical complications, such as infection or fracture.
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
Patients' experiences of undergoing surgery and rehabilitation with reverse shoulder arthroplasty.
Time frame: From time of surgery to end of rehabilitation, approximately 0-7,8 months.
Qualitative semi structured individual in-depth interviews were analysed using qualitative content analysis. Fifteen persons, women and men, who had undergone surgery with reverse shoulder arthroplasty between six to twelve months previously, were recruited to the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- 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.
Anette Larsson, RPT, PhD study chair
Research, Education, Development & Innovation, Primary Health Care, Region Västra Götaland, Sweden.
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 of the Shoulder, run by Vastra Gotaland Region at 1 site in Sweden.
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: finished, as of the sponsor's last update on 13 Jun 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 Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients' experiences of undergoing surgery and rehabilitation with reverse shoulder arthroplasty. (time frame: From time of surgery to end of rehabilitation, approximately 0-7,8 months.). 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 13 Jun 2025.