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| Name | Class |
|---|---|
| Zimmer, GmbH | INDUSTRY |
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The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shoulder Arthroplasty | Other | Patients in need of a shoulder arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative CT Scan | Radiation | Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CT scan data acquisition | The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. | Immediate post-op |
| Intra-op bone quality evaluation: Thumb Test | The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient. | Intra-op |
| Intra-op bone quality evaluation: Pin Test | The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak. | Intra-op |
| Intra-op bone quality evaluation: Broach Test | The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended. | Intra-op |
| Duplicate CT scan data acquisition (Optional) | Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study. | Immediate post-op |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional Performance (Optional): Constant & Murley Score | The Constant & Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. | Pre-op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elliott Goff, PhD | Contact | 41792222308 | elliott.goff@zimmerbiomet.com | |
| Ghislain Maquer | Contact | ghislain.maquer@zimmerbiomet.com |
| Name | Affiliation | Role |
|---|---|---|
| Elliott Goff, PhD | Zimmer, GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joint Surgery, Sports Clinic Ishinomaki | Ishinomaki | Miyagi | Japan |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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