Primary or Secondary Omarthrosis of the Shoulder JointPromosNCT00925496
Patient Benefit From the New Modular Shoulder Prosthesis PROMOS
An observational study of Primary or Secondary Omarthrosis of the Shoulder Joint, run by Smith & Nephew Orthopaedics AG at 2 sites in 2 countries.
Trial summary
Overall study design: This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary or Secondary Omarthrosis of the Shoulder Joint
- How many people
- 155 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2009to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
- Massive rotator cuff rupture
- Willing an able to give written informed consent to participate in the study including follow-ups
Who cannot join
- Previous ipsilateral shoulder arthroplasty (group A and B)
- Late stage rotator cuff disease (only group A)
- Acute shoulder trauma (group A and B)
- General medical contraindication to surgery (group A and B)
- Legal incompetence (group A and B)
- Tumour / malignoma (group A and B)
Show all 10Show fewer
- Recent history of substance abuse (group A and B)
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) (group A and B)
- Known hypersensitivity to the materials used (group A and B)
- Bacterial infection at the time point of operation (group A and B)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
Overall study design:
This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.
Read the detailed description
Primary objective of the study:
The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real world approach). Patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (ADL) and quality of life (QoL).
Secondary objectives:
- Rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures
- Prosthesis survival at common time points, e.g. 5 and 10 years
- Keywords
- Omarthrosis shoulder joint
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 |
|---|---|---|
| Standard PROMOS prosthesis | Patients receiving a standard PROMOS prosthesis | |
| Reverse PROMOS prosthesis | Patients receiving a reverse PROMOS prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.
Measured: Preop / 6M / 1Y / 2Y / 5Y / 10Y
Secondary outcomes (1)
Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years
Measured: Preop / 6M / 1Y / 2Y / 5Y / 10Y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary or Secondary Omarthrosis of the Shoulder JointStudies 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
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Kaspar Schwyzer, Dr. med., Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925496
- Sponsor's protocol ID
- D10054
- Acronym
- Promos
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2009
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Benefit From the New Modular Shoulder Prosthesis PROMOS - a Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT00925496
- Acronym / sponsor ID
- Promos / D10054
- Keywords
- Omarthrosis shoulder joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 22 Jun 2009 (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.
Overall study design:
This study is a prospective, non-randomized, multicenter postmarket clinical follow-up study with two study arms using the two shoulder prosthesis PROMOS™ STANDARD (group A) and PROMOS REVERSE™ (group B). The study will collect efficacy and safety data over 10 years.
Detailed description
Primary objective of the study:
The primary objective is to quantify patient benefit after primary total shoulder arthroplasty with the modular PROMOS™ shoulder system in a multicenter cohort study (real world approach). Patient benefit will be quantified using objective and validated subjective measures of function, activities of daily living (ADL) and quality of life (QoL).
Secondary objectives:
- Rate of implant related findings like radiological loosening of the glenoid and complications like intraoperative stem fissures
- Prosthesis survival at common time points, e.g. 5 and 10 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard PROMOS prosthesis | – | –Patients receiving a standard PROMOS prosthesis |
| Reverse PROMOS prosthesis | – | –Patients receiving a reverse PROMOS prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- Primary or secondary omarthrosis as an indication for primary total shoulder arthroplasty
- Massive rotator cuff rupture
- Willing an able to give written informed consent to participate in the study including follow-ups
Key exclusion criteria (10 listed)
- Previous ipsilateral shoulder arthroplasty (group A and B)
- Late stage rotator cuff disease (only group A)
- Acute shoulder trauma (group A and B)
- General medical contraindication to surgery (group A and B)
- Legal incompetence (group A and B)
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
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool.
Time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
1 secondary outcome
Active and passive ROM and strength / Rate of implant related complications / Rate of implant related findings like radiological loosening of the glenoid / Prosthesis survival at common time points, e.g. 5 and 10 years
Time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y
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 6 Apr 2020.
- Individual participant dataSharing planned: Undecided
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.
Hans-Kaspar Schwyzer, Dr. med. principal investigator
Schulthess Klinik
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary or Secondary Omarthrosis of the Shoulder Joint, run by Smith & Nephew Orthopaedics AG at 2 sites in 2 countries.
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 3 inclusion and 10 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. 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?
Primary outcome measures: Patient benefit will be measured with the SPADI and Constant Murley score at the joint level, with the QuickDASH for the upper extremity and the SF-36 mental score as a generic tool. (time frame: Preop / 6M / 1Y / 2Y / 5Y / 10Y). 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 6 Apr 2020.