Primary and Secondary Omarthrosis
Conditions
Brief 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.
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.
Interventions
DEVICEstandard PROMOS prosthesis
Sponsors
Smith & Nephew Orthopaedics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* acute shoulder trauma * tumor / malignoma * avascular necrosis * late stage rotator cuff disease * Charcot joint disease or other severe neurosensory deficits * high comorbidity * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Score | 10 Years | 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. |
| ASES Shoulder Score Index | 10Years | 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. |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Promos™ Standard Shoulder System All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Death | 14 |
| Overall Study | Lost to Follow-up | 42 |
Baseline characteristics
| Characteristic | Promos™ Standard Shoulder System |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 11.4 |
| Body Mass Index | 26.81 kg/m2 STANDARD_DEVIATION 4.45 |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 87 |
| serious Total, serious adverse events | 31 / 87 |
Outcome results
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.
Time frame: up to 10 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Promos™ Standard Shoulder System | Radiological and Clinical Loosening Rates of the Glenoid and Humeral Components | 96.29 Percentage survivorship |
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.
Time frame: 10Years
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promos™ Standard Shoulder System | ASES Shoulder Score Index | 76.88 units on a scale | Standard Deviation 18.21 |
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.
Time frame: 10 Years
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Promos™ Standard Shoulder System | Constant Murley Score | 72.80 units on a scale | Standard Deviation 16.89 |