Humerus FractureRTESSNCT01877434
Reversed TESS Shoulder Artroplasty
An observational study of Humerus Fracture and Degenerative Shoulder Pain, run by Sundsvall Hospital at 1 site in Sweden.
Trial summary
Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination… Read more about this study
- Who is it for?
- Ages 60 to 88 years
- Conditions the study is for
- Humerus Fracture, Degenerative Shoulder Pain, Degenerative Supraspinatus Rupture
- What is being tested?
- Reversed shoulder arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2007to Jun 2013
- 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 60 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergone reversed shoulder arthroplasty at Sundsvall hospital, Sweden between 2007-2012
Who may be able to join
- Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.
Who cannot join
- Do not give informed consent
- Do not attend follow-up
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Institution of surgical and operative sciences, Umeå University
Sundsvall, Västernorrland Län
About this study
Official title: The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up
Reverse total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.
- Being tested
- Reversed shoulder arthroplasty
- Keywords
- Reversed shoulder arthroplasty, Treatment, TESS
- Medical subject headings
- Humeral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversed shoulder arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Reversed TESS | Patient undergone reversed shoulder arthroplasty Receives: Procedure: Reversed shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported outcome measurement Quick-DASH
Measured: 2007-2013
Secondary outcomes (2)
Range of movement
Measured: 2007-2013
Quality of life EQ5-D
Measured: 2007-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startOct 2007
- Primary completionJan 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humerus FractureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennart Bråbäck, Sundsvall Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877434
- Sponsor's protocol ID
- 2012-201-31M
- Acronym
- RTESS
- Status last verified
- Jun 2013
- First submitted
- 11 Jun 2013
- Last updated
- 13 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TESS Reverse Shoulder Arthroplasty: Effect of Arm Lengthening and Early Scapular Notching at Three Years Follow-up
- ClinicalTrials.gov ID
- NCT01877434
- Acronym / sponsor ID
- RTESS / 2012-201-31M
- Keywords
- Reversed shoulder arthroplasty, Treatment, TESS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- 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 total shoulder arthroplasty (RSA) is a accepted treatment for different shoulder diseases with improved functional outcome. This study has evaluated patients operated with reversed shoulder arthroplasty after 1,5-3 years postoperatively with patient reported outcome, clinical and radiological examination, complication and reoperations. The radiologic phenomenom and clinical impact of scapular notching (SN) and arm length difference has been evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reversed TESS | – | Procedure: Reversed shoulder arthroplastyPatient undergone reversed shoulder arthroplasty |
Who may qualify
- Ages
- 60 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone reversed shoulder arthroplasty at Sundsvall hospital, Sweden between 2007-2012
Key inclusion criteria (1 listed)
- Operated with a reversed TESS total shoulder arthroplasty at Sundsvall hospital.
Key exclusion criteria (2 listed)
- Do not give informed consent
- Do not attend follow-up
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 |
|---|---|---|
| Reversed shoulder arthroplasty | Procedure or surgery | Reversed TESS |
Primary outcome
Patient reported outcome measurement Quick-DASH
Time frame: 2007-2013
2 secondary outcomes
Range of movement
Time frame: 2007-2013
Quality of life EQ5-D
Time frame: 2007-2013
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 2013.
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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 Humerus Fracture and Degenerative Shoulder Pain, run by Sundsvall Hospital 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 2 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 2013. 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?
Patient reported outcome measurement Quick-DASH (time frame: 2007-2013). 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 2013.