Primary and Secondary OmarthrosisNCT02280499
Multicenter Clinical Observation PROMOS®
An observational study of Primary and Secondary Omarthrosis, run by Smith & Nephew Orthopaedics AG.
Trial summary
Overall study design: This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary and Secondary Omarthrosis
- What is being tested?
- standard PROMOS prosthesis
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patient has no general medical contraindication to surgery
- informed consent to participate in the observation signed by the patient
- routine radiographic assessment is possible
- patient is likely to comply with study follow-up requirements
- primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral
Who cannot join
- acute shoulder trauma
- tumor / malignoma
- avascular necrosis
- late stage rotator cuff disease
- Charcot joint disease or other severe neurosensory deficits
- high comorbidity
Show all 12Show fewer
- previously failed shoulder arthroplasty
- fracture sequelae of proximal humerus
- hypersensitivity to the implant materials used
- addictive disorders such as alcohol or drug abuse
- severe spinal disorders
- bacterial infections
About this study
Overall study design:
This study is a prospective, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.
Read the detailed description
Primary objective:
Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant.
At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point.
Secondary objectives:
The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.
- Conditions
- Primary and Secondary Omarthrosis
- Being tested
- standard PROMOS prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard PROMOS prosthesisDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.
Measured: up to 10 years
Secondary outcomes (2)
Constant Murley Score
The Constant Murley Score is a shoulder outcome score to determine the functionality of the shoulder after the treatment of a shoulder injury. The score ranges from 0 to 100 with a higher score indicating better shoulder function.
Measured: 10 Years
ASES Shoulder Score Index
The American Shoulder and Elbow Surgeon's (ASES) evaluation is used to document the improvement in pain, function and range of motion after shoulder injury. The ASES Shoulder Score Index is calculated from the ASES patient related questionnaire and ranges from 0-100 with a higher score indicating improvement in pain and function.
Measured: 10Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2003
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary and Secondary OmarthrosisStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280499
- Sponsor's protocol ID
- D8240-1
- Status last verified
- Feb 2016
- First submitted
- 29 Oct 2014
- Last updated
- 21 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Observation PROMOS®
- ClinicalTrials.gov ID
- NCT02280499
- Acronym / sponsor ID
- D8240-1
- Conditions
- Primary and Secondary Omarthrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 21 Mar 2016
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, multicenter, postmarket clinical observation to validate the PROMOS™ Standard Shoulder System as state-of-the-art implant system for total shoulder arthroplasty in terms of radiographic and clinical performance as well as long-term survivorship over 10 years.
Detailed description
Primary objective:
Radiological and clinical loosening rates of the glenoid and humeral components must be comparable or below the rates of other well documented state-of-the-art shoulder systems with cemented glenoid components. Complications occurring intra- or postoperatively will be assessed and sub-classified in their relation to the implant.
At the end of the observation, a long-term survival rate will be calculated according to Kaplan-Meier with revision due to aseptic loosening as the end-point.
Secondary objectives:
The Constant Murley score and the ASES clinical evaluation are used for documenting the improvement in pain, function and range of motion. For the patient's subjective view of improvement in function a patient self-assessment form is used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 (5 listed)
- patient has no general medical contraindication to surgery
- informed consent to participate in the observation signed by the patient
- routine radiographic assessment is possible
- patient is likely to comply with study follow-up requirements
- primary total- or hemi-shoulder-arthroplasty to the affected side, unilateral or bilateral
Key exclusion criteria (12 listed)
- acute shoulder trauma
- tumor / malignoma
- avascular necrosis
- late stage rotator cuff disease
- Charcot joint disease or other severe neurosensory deficits
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 |
|---|---|---|
| standard PROMOS prosthesis | Device | – |
Primary outcome
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components
Time frame: up to 10 years
The long-term survival rate of the Promos™ Standard shoulder system was calculated with revision due to aseptic loosening as endpoint using a Kaplan-Meier Analysis.
2 secondary outcomes
Constant Murley Score
Time frame: 10 Years
ASES Shoulder Score Index
Time frame: 10Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary and Secondary Omarthrosis, run by Smith & Nephew Orthopaedics AG.
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 12 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 21 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components (time frame: up to 10 years). 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 21 Mar 2016.