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Termination of PMCF study due to product discontinuation.
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The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.
The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASHCOM Shoulder System subjects | Subjects implanted with the ASHCOM Shoulder System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASHCOM Shoulder System | Device | Reverse Shoulder Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival of Implant System (Kaplan Meier) | The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM) | The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome). |
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Inclusion Criteria:
Exclusion Criteria:
Patient is unwilling or unable to give consent or to comply with the follow-up program.
Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
Patient is known to be pregnant or breastfeeding.
Patient is a vulnerable subject.
Patient meets at least one of the contraindications:
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Patients suffering from severe shoulder pain and disability indicated for implantation of the ASHCOM Shoulder System and who meet all inclusion and none of the exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Marcello Stamilla, MD | Clinica del Mediterraneo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica del Mediterraneo | Ragusa | 97100 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | ASHCOM Shoulder System Subjects - Uncemented Humeral Stem | Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty |
| FG001 | ASHCOM Shoulder System Subjects - Fracture Humeral Stem | Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ASHCOM Shoulder System Subjects - Uncemented Humeral Stem | Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem ASHCOM Shoulder System: Reverse Shoulder Arthroplasty |
| BG001 | ASHCOM Shoulder System Subjects - Fracture Humeral Stem |
| 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 | Survival of Implant System (Kaplan Meier) | The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. Due to early study termination, the survival of the implant was analyzed at 3 years. | Posted | Count of Participants | Participants | 3 years |
|
AEs were collected from the time of surgery until study termination (up to 3 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 | ASHCOM Shoulder System Subjects - Uncemented Humeral Stem | Subjects implanted with the ASHCOM Shoulder System and an uncemented humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Not study related death | General disorders | Non-systematic Assessment | Patient died from Covid two months after surgery |
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Limitations of this study are the low overall sample size of 24 cases as well as the short follow-up period of three years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carina Hafner | Zimmer Biomet | +41797073093 | carina.hafner@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2018 | Feb 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D020069 | Shoulder Pain |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| Pre-operative (baseline), 1 year, 2 years post-operative |
| Oxford Shoulder Score (OSS) | The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19. | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative |
| EQ-5D-5L Score | The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst. | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative |
| Subjective Shoulder Value (SSV) | The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal. | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative |
| Radiographic Parameters | Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching | 2 years post-operative |
Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem ASHCOM Shoulder System: Reverse Shoulder Arthroplasty |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Preop BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | The Performance and Clinical Benefits of the ASHCOM Shoulder System - Constant Murley Shoulder Score (CM) | The secondary endpoint of this study is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Due to early study termination, the Constant and Murley Score was assessed at 2 years. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome). | The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline), 1 year, 2 years post-operative | Implants | Implants |
|
|
|
|
| Secondary | Oxford Shoulder Score (OSS) | The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following total shoulder arthroplasty. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible and a minimum of 0, representing the worst possible. The outcome score can be categorized as: Satisfactory Joint Function: 40 - 48, Moderate-Mild Arthritis: 30 - 39, Moderate-Severe Arthritis: 20 - 29, Severe Arthritis: 0 - 19. | The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 2 years follow-up. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative | Implants | Implants |
|
|
|
|
| Secondary | EQ-5D-5L Score | The EQ-5D-5L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573. It included the Health State, which is a self-reported assessment about the patient's health on that day at a VAS from 0 to 100 with 100 being the best health one can imagine and 0 the worst. | The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit and for one patient the score was not collected at the 3-6 months and 1 year follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative |
|
|
|
|
| Secondary | Subjective Shoulder Value (SSV) | The Subjective Shoulder Value (SSV) is a single point, subjective estimate of a patient's condition. The patient is asked to rate the functionality of their operated shoulder on a scale of 0% - 100% of normal. | The number analyzed in one or more rows differs from overall number analyzed, as one patient passed away prior to the 3-6 month visit. For one patient the score was not collected at the 3-6 months follow-up visit and for two patients at the 1 year follow-up visit. | Posted | Mean | Standard Deviation | percentage of normal | Pre-operative (baseline), 3-6 months, 1 year, 2 and 3 years post-operative | Implants | Implants |
|
|
|
|
| Secondary | Radiographic Parameters | Radiographic parameters: X-rays have been evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes (glenoid), component migration (humeral stem subsidence / glenoid component migration), heterotopic ossification and scapular notching | ASHCOM Shoulder System subjects - Uncemented humeral stem: The number analyzed at 2 years is 21, as one patient passed away prior to the 3-6 month visit. | Posted | Count of Participants | Participants | 2 years post-operative |
|
|
|
| 1 |
| 22 |
| 1 |
| 22 |
| 0 |
| 22 |
| EG001 | ASHCOM Shoulder System Subjects - Fracture Humeral Stem | Subjects implanted with the ASHCOM Shoulder System and a fracture humeral stem. ASHCOM Shoulder System: Reverse Shoulder Arthroplasty | 0 | 2 | 0 | 2 | 0 | 2 |
|
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| D018771 |
| Arthralgia |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 2 years |
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