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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard PROMOS prosthesis | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 Years |
| ASES Shoulder Score Index |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
93 patients were assessed for eligibility. Two participants were excluded before receiving the intervention due to not meeting the inclusion criteria.
Four enrolled subjects did not receive a PROMOS™ prosthesis due to different reasons but were changed to another shoulder implant which was not part of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Promos™ Standard Shoulder System | All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Promos™ Standard Shoulder System | All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | Percentage survivorship | up to 10 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Promos™ Standard Shoulder System | All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial Plexus paresis | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subacromial Impingement | Musculoskeletal and connective tissue disorders |
One limitation of the study relates to the small number of subjects available at the 10 year interval for final analysis due to the early termination of 2 sites.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evita Leiber, Clinical Study Manager | Smith & Nephew | +41 41 766 2205 | evita.leiber@smith-nephew.com |
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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. |
| 10Years |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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|
|
| Secondary | 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. | As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The Constant Murley Score was incomplete for 3 participants and therefore the number of participants analyzed is 23. | Posted | Mean | Standard Deviation | units on a scale | 10 Years |
|
|
|
| Secondary | 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. | As per the study flow chart, 26 study participants had a 10 year follow-up visit to collect the data supporting the primary outcome measure. The ASES Shoulder Score Index was calculated for 27 participants. As the score is a patient reported outcome the score could be completed at home increasing the number of available scores. | Posted | Mean | Standard Deviation | units on a scale | 10Years |
|
|
|
| 31 |
| 87 |
| 2 |
| 87 |
| Fall - traum. rupture of subscapularis | Musculoskeletal and connective tissue disorders |
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| Total shoulder arthroplasty contralateral side | Musculoskeletal and connective tissue disorders |
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| Stroke | Blood and lymphatic system disorders |
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| Pulmonary Embolism | Blood and lymphatic system disorders |
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| Heart attack | Blood and lymphatic system disorders |
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| Trauma (abduction and rotation) | Musculoskeletal and connective tissue disorders |
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| Pneumonia | Infections and infestations |
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| Migration of humeral component | Musculoskeletal and connective tissue disorders | Rotator cuff led to sup. migration of humeral component |
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| Thrombosis right leg | Blood and lymphatic system disorders |
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| Glenoid loosening | Musculoskeletal and connective tissue disorders |
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| Death | General disorders |
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| Revision of study device | Investigations |
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| No active mobilization after surgery due to pain | Musculoskeletal and connective tissue disorders |
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