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This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement.
This study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the PyroTITAN™ HRA Shoulder prosthesis humeral replacement. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
The investigation will be conducted by up to 10 International surgeons experienced in HRA. 387 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary cohort | Primary cohort will receive the PyroTITAN HRA device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PyroTITAN HRA | Device | Humeral resurfacing using the PyroTITAN HRA device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Survival | Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following:
| up to 117 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Success | Radiographic success determined by:
| 2 years, 3 years, 4 years, 5 years, 8 years and 10 years |
Not provided
Inclusion Criteria:
Patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
Subject is able to or capable of providing consent to participate in the clinical investigation.
Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires.
Subject is at least 21 years of age and skeletally mature at the time of surgery.
Exclusion Criteria:
Have destruction of the proximal humerus to preclude rigid fixation of the humeral component.
Insufficient bone quality as determined by intra-operative evaluation.
Have arthritis with defective rotator cuff.
Have had a failed rotator cuff surgery.
Have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
Have evidence of active infection.
Present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint).
Are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol.
Are skeletally immature.
Have a known allergic reaction to pyrocarbon.
Have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible.
Are currently participating in another clinical study.
Have known, active metastatic or neoplastic disease.
Are taking > 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery.
Are under 21 years of age or over 75.
.
Require glenoid replacement (Glenoid Classification).
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Subjects who require humeral head resurfacing arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| Julie Lankiewicz | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brisbane Hand & Upper Limb Clinic | Brisbane | Queensland | 4001 | Australia | ||
| Barwon Health |
The Full Analysis Set (FAS) population includes 10 participants that received the TITAN device and 146 participants that received the PyroTITAN device. The TITAN device was renamed PyroTITAN by the previous sponsor (i.e., the same device). All participants were enrolled the same based on the eligibility criteria, so all participants are combined under the same primary cohort.
Overall, 156 participants were enrolled to the study at five (5) sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Primary Cohort | Primary cohort will receive the PyroTITAN HRA device* PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set Population (FAS), following Intent-to-Treat principle included all participants enrolled into the study with data collected. This population includes 10 participants that received the TITAN device and 146 participants that received the PyroTITAN device. The TITAN device was renamed PyroTITAN by the previous sponsor (i.e., the same device). All participants were enrolled the same based on the eligibility criteria, so all participants are combined under the same primary cohort.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Primary Cohort | Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device |
| 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 | Device Survival | Clinical success was determined by the percentage of shoulders with device survival. Survival of the device was measured by the Kaplan-Meier survival estimate with survival defined as all the following:
| Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. | Posted | Number | 95% Confidence Interval | percentage of shoulders | up to 117 months | shoulders | shoulders |
|
Adverse events were collected upon implantation of the study device to the end of study, up to 10 years.
Ascension Orthopedics Inc. conducted monitoring & reporting responsibilities from study start to December 2020. Upon acquisition, Smith+Nephew's Adverse Event Monitoring Board (AEMB) reviewed & classified all adverse events from January 2021 to the end of study, following ISO 14155 guidelines. It is unknown how the previous sponsor classified adverse events. 10 participants that received the TITAN device are combined with PyroTITAN due to renaming of the device as explained in Participant Flow.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary Cohort | Primary cohort will receive the PyroTITAN HRA device PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL HERNIA | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AXILLARY NERVE DAMAGE RIGHT SHOULDER | Nervous system disorders | Systematic Assessment |
The study was managed by Ascension Orthopedics, Inc prior to Smith+Nephew Inc. (Memphis) becoming the sponsor in January 2021. This study was not designed nor controlled/monitored by Smith+Nephew Inc. (Memphis), except for the final follow-up phase. The data reported is based on the data available since the time of Smith+Nephew's acquisition of Ascension Orthopedics, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | +44 7811 407089 | datasharing.gcs@smith-nephew.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2013 | Jan 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 5, 2023 | Jan 13, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ASES Score |
The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition. |
| Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| Visual Analog Scale (VAS) Pain Score | The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome). | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| Visual Analog Scale (VAS) Satisfaction Score | Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome). | 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| The Western Ontario of the Shoulder Index (WOOS) Score | The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition. | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| Constant-Murley (CM) Score | The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome). | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| EQ-5D-3L Quality of Life Score | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome). | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| EQ-5D-3L VAS Score | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome). | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
| Geelong |
| Victoria |
| 3220 |
| Australia |
| Institut Nices | Nice | 06000 | France |
| Danderyd Hospital | Stockholm | S-182 88 | Sweden |
| Wrightington Hospital | Wigan | Wrightington | WN6 9EP | United Kingdom |
| 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 |
|
| Body Mass Index (BMI) | Number of participants analyzed indicated participants with data collected for the baseline measure specified. | Mean | Standard Deviation | kg/m^2 |
|
Primary cohort will receive the PyroTITAN HRA device
PyroTITAN HRA: Humeral resurfacing using the PyroTITAN HRA or TITAN device
|
|
| Secondary | Radiographic Success | Radiographic success determined by:
| Radiographic outcome data were not collected during the study period by the original sponsor, despite being specified in the protocol. As a result, this outcome measure could not be analyzed or reported. This limitation does not affect the reporting of other pre-specified primary and secondary outcomes, which have been summarized and submitted as per protocol. | Posted | 2 years, 3 years, 4 years, 5 years, 8 years and 10 years |
|
|
| Secondary | ASES Score | The ASES Shoulder Score is a functional outcome tool that has been validated for various shoulder conditions. ASES score ranges from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition. | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | Visual Analog Scale (VAS) Pain Score | The Visual Analog Scale (VAS) Pain Score ranges from 0 to 100, with 0 representing no pain (i.e., the best outcome) and 100 representing the worst possible pain (i.e., the worst outcome). | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | Visual Analog Scale (VAS) Satisfaction Score | Patient satisfaction determined by the Visual Analog Scale (VAS) Satisfaction score. VAS Satisfaction scores range from 0 to 100, with 0 representing the lowest level of satisfaction (i.e., the worst possible outcome) and 100 representing the highest level of satisfaction (i.e., the best possible outcome). | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | The Western Ontario of the Shoulder Index (WOOS) Score | The WOOS Score is a quality of life questionnaire that has been validated for various shoulder conditions. WOOS total score ranges from 0 to 100, with 0 representing the best shoulder condition and 100 representing the worst shoulder condition. | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | Constant-Murley (CM) Score | The Constant-Murley (CM) Score is a commonly used score of shoulder function. CM scores range from 0 to 100, with a score of 0 indicating a worse shoulder function (i.e., worst outcome) and 100 indicating the best shoulder function (i.e., best outcome). | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | EQ-5D-3L Quality of Life Score | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Quality of Life Score ranges on a scale of 0 to 1, with 0 indicating a worse health condition (i.e., worst outcome) and 1 indicating the best health condition (i.e., best outcome). | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| Secondary | EQ-5D-3L VAS Score | The EuroQol 5-Dimension 3-Level (EQ-5D-3L) Visual Analog Scale (VAS) Score ranges on a scale of 0 to 100, with 0 indicating a worse health condition (i.e., worst outcome) and 100 indicating the best health condition (i.e., best outcome). | Full Analysis Set Population (FAS) followed the Intent-to-Treat principle that included all participants enrolled with data collected for the outcome and time frame specified. Ten (10) participants received the TITAN device instead of the PyroTITAN device. These 10 participants were included in the FAS population as they were enrolled similarly to all other participants. Data for 19 participants at 1 site excluded from analysis because data collection occurred using an incorrect CM format. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 8 years, and 10 years |
|
|
|
| 7 |
| 156 |
| 51 |
| 156 |
| 36 |
| 156 |
| AGGRAVATION OF HERNIATED DISC | General disorders | Systematic Assessment |
|
| ANGINA ON EXERTION | Cardiac disorders | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | Systematic Assessment |
|
| ARTHRITIS IN LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ARTHRITIS IN RT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| BENIGN TUMOUR IN RIGHT KNEE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| BILATERAL ROTATOR CUFF DEGENERATION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| BROKEN LEFT WRIST | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIAC ARRHYTHMIA | Cardiac disorders | Systematic Assessment |
|
| CHEST PAIN ON EXERTION | Cardiac disorders | Systematic Assessment |
|
| CRACK IN PROSTHESIS | Product Issues | Systematic Assessment |
|
| CUT ON LEFT INDEX FINGER USING DROP SAW | General disorders | Systematic Assessment |
|
| DEVICE BREAKAGE | Product Issues | Systematic Assessment |
|
| DIVERTICULITIS | Gastrointestinal disorders | Systematic Assessment |
|
| FRACTURE IN HEAD OF IMPLANT | Product Issues | Systematic Assessment |
|
| FRACTURE OF PYROTITAN IMPLANT | Product Issues | Systematic Assessment |
|
| FRACTURED IMPLANT/PYROTITAN | Product Issues | Systematic Assessment |
|
| GALL STONES | Renal and urinary disorders | Systematic Assessment |
|
| IMPLANT BREAKAGE | Product Issues | Systematic Assessment |
|
| IMPLANT BREAKAGE RIGHT SHOULDER | Product Issues | Systematic Assessment |
|
| IMPLANT FRACTURE DUE TO A FALL | Product Issues | Systematic Assessment |
|
| INCREASING LEFT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| INFLUENZA A | Infections and infestations | Systematic Assessment |
|
| INFLUENZA TYPE A | Infections and infestations | Systematic Assessment |
|
| KIDNEY STONES | Renal and urinary disorders | Systematic Assessment |
|
| LEFT ELBOW PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| MELANOMA (CLARKS LEVEL 4) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| MELANOMA (LEFT BIG TOE) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| MULTIPLE SCLEROSIS | Nervous system disorders | Systematic Assessment |
|
| NECTROTISING INFLAMMATION OF RIGHT LUNG | Infections and infestations | Systematic Assessment |
|
| NERVE PAIN IN LOWER BACK EXACERBATED | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ONGOING LEFT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PERSISTENT PAIN IN RIGHT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| PROSTATE INFECTION | Renal and urinary disorders | Systematic Assessment |
|
| RADIAL NERVE PALSY | Nervous system disorders | Systematic Assessment |
|
| REACTION TO IV DYE | General disorders | Systematic Assessment |
|
| REFLUX | Gastrointestinal disorders | Systematic Assessment |
|
| REVERSE TOTAL PROSTESIS LEFT SHOULDER | Product Issues | Systematic Assessment |
|
| RIGHT ELBOW PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT HAND CARPAL TUNNEL SYNDROME | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT HIP BURSITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT KNEE PAIN / MENISCUS TEAR | Cardiac disorders | Systematic Assessment |
|
| RIGHT ROTATOR CUFF INJURY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT ROTATOR CUFF TENDONITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RIGHT SHOULDER TENDINOPATHY | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| RUPTURED SPINAL DISCS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| STAGE 3 CHRONIC KIDNEY DISEASE. | Renal and urinary disorders | Systematic Assessment |
|
| STAPH INFECTION IN RIGHT FOREARM | Infections and infestations | Systematic Assessment |
|
| STONE IN GALL BLADDER | Renal and urinary disorders | Systematic Assessment |
|
| STROKE | Vascular disorders | Systematic Assessment |
|
| STROKE | Nervous system disorders | Systematic Assessment |
|
| STROKE ATTACK | Nervous system disorders | Systematic Assessment |
|
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | Systematic Assessment |
|
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| TIA | Vascular disorders | Systematic Assessment |
|
| TORN RETINA IN RIGHT EYE | Eye disorders | Systematic Assessment |
|
| TRAUMA TO THE LEFT KNEE. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING (R) SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING ARTHRITIS IN RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING ARTHRITIS PAIN LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING KNEE PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING KNEE PAIN (CATCHING) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OA IN LEFT AND RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OA IN LEFT AND RIGHT KNEE due to BILATERAL TOTAL KNEE REPLACEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OA IN LEFT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OA RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF BILATERAL KNEE OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF LEFT KNEE OA. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF LEFT KNEE OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF LEFT SHOULDER OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF OA IN LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF OA IN RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF OA IN RIGHT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF OA IN RIGHT THUMB | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF PRE-EXISTING BACK PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF PRE-EXISTING HERNIA | General disorders | Systematic Assessment |
|
| WORSENING OF RIGHT KNEE PAIN/ARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF RIGHT SHOULDER OA. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF RIGHT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OSTEOARTHRITIS IN LEFT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING PAIN IN RIGHT KNEE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING R) HIP OA | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CUFF TENDINITIS IN RIGHT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ONGOING PAIN IN LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| INCREASED PAIN IN OPERATIVE SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LEFT SHOULDER NERVE IMPINGEMEN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PERSISTENT RIGHT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LEFT SHOULDER PAIN | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SEVERE INCREASE IN LEFT SHOULDER PAIN. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LEFT ROTATOR CUFF TENDONITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| MARGINAL OSTEOPHYTE R GLENOID | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| CYSTIC CHANGES IN GLENOID NOTED ON MRI | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| TRANSIENT SQUEAK | General disorders | Systematic Assessment |
|
| HAD TREE FALL ON BACK AND SHOULDER | General disorders | Systematic Assessment |
|
| LUCENT FRACTURE | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| WORSENING OF RIGHT MCP AND CMCJ OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| "SQUEAKING" SOUND FROM JOINT OF RIGHT SHOULDER WITH MOVEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PINS-AND-NEEDLES IN R THUMB/INDEX/MIDDLE FINGER, RADIATING TO ELBOW AND INTO R BREAST | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| VAGAL EPISODE (DIZZY / FAINTING) POST SURGERY SECONDARY TO PAIN | General disorders | Systematic Assessment |
|
| TENDONITIS OF LEFT SHOULDER- CLICKING/PAINFUL SENSATION WITH SHOULDER MOVEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PAIN AND WEAKNESS IN RIGHT SHOULDER WHEN OVERWORKED. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ROTATOR CUFF TENDINOPATHY OF RIGHT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| SQUEAKING SOUND IN LEFT SHOULDER / PYROTITAN WITH MOVEMENT OF SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| PERSISTENT PAIN IN ANTERIOR LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| OCCASIONAL SQUEAK FROM IMPLANT. NOT PAINFUL | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| ROTATOR CUFF DYSFUNCTION IN RIGHT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| LEFT SIDED FORAMINA STENOSIS AT C5 AND C6 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| INCREASED GRINDING/CLICKING IN LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| NERVE DISTURBANCE IN DISTRIBUTION OF MUSCULOCUTANEOUS NERVE AND/OR C6/C7 | Nervous system disorders | Systematic Assessment |
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| SQUEAK IN RIGHT SHOULDER JOINT WITH MOVEMENT | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| MINIMAL INFERIOR OSTEOPHYTE GLENOID. - XR + MRI REPORT. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| ASYMPTOMATIC MARKED SUBARTICULAR CYSTIC CHANGES INVOLVING MID AND SUPERIOR GLENOID | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| SQUEAKING NOTED BY PATIENT FROM LEFT SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| SUBCORTICAL CYST IN POSTERIOR GLENOID INCREASED IN MEASUREMENT (UP TO 11MM) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| DIFFICULTY IMPLANTING (DIFFICULTY BROACHING, REAMING AND INSERTING) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| OCCASSIONAL SQUEAK NOTED IN OPERATIVE SHOULDER | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| FELL ONTO A OUTSTRETCHED ARM. NOW PAINFUL, TIGHT IN DELTOID REGION | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| PROSTHETIC LOOSENING | General disorders | Systematic Assessment |
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| FALL OFF BACK OF CAMPING BUS 1.5 METRES | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| RADIAL NERVE PALSY | Nervous system disorders | Systematic Assessment |
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| ANTERIOR DELTOID ATROPHY MODERATE STIFFNESS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| NERVE PAIN AND MILD LOSS OF SENSIBILITY IN DIGITS 1 AND 2 LEFT HAND | Nervous system disorders | Systematic Assessment |
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| SUFFERED A FISSURE FRACTURE COLLUM CHIRURGICUM LEFT SIDE. | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. Sponsor may delay publication up to 120 days to permit the filing of appropriate patent applications if the sponsor believes any publication contains any information relating to patentable items and cannot extend the embargo.
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