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The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity.
The study is designed as a single center, post-market, non-randomized, open-label, observational clinical study with retrospective and prospective enrollment to evaluate the 2-year post implantation survivorship of the PyroTITAN™ HRA device following the implementation of a new proof test to identify and eliminate devices with sub-standard mechanical integrity. The results will be compared to data collected in a prior study conducted before implementing the new proof test. The PyroTITAN™ HRA Shoulder prosthesis device configuration will include humeral resurfacing CAP without cement. Patients will be selected retrospectively and prospectively for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty.
137 subjects with PyroTITAN™ HRA Shoulder prosthesis arthroplasties will be implanted and followed for up to 60 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PyroTITAN™ HRA | Device | Humeral Resurfacing |
| Measure | Description | Time Frame |
|---|---|---|
| Device Survival: Kaplan-Meir Estimate | Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device-Related Adverse Events | Count of participants with device-related Non-Serious & Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment. | Post-operatively to 5-Years |
| Cumulative Device Success |
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Inclusion Criteria:
Patients of either sex will be included, if they:
Present (prospective cohort) or presented (retrospective cohort) for primary shoulder surface replacement or arthroplasty with any of the following diagnoses:
Subject receives (prospective cohort) the PyroTITAN HRA device after the re-release of the product or received (retrospective cohort) the PyroTITAN HRA device after the re- release of the product and is enrolled in the study prior to their two-year follow-up visit.
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 18 years of age and skeletally mature at the time of surgery.
Exclusion Criteria:
Patients will be excluded from participation if they:
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Subjects who require humeral head resurfacing arthroplasty.
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| Name | Affiliation | Role |
|---|---|---|
| Belinda Larson | Smith & Nephew, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brisbane Hand and Upper Limb Research Institute | Brisbane | Queensland | 4001 | Australia |
Overall, 137 participants were enrolled in the study, and fifty-two (52) participants discontinued from the study before completion.
Participants were enrolled in the study at one (1) site in Australia and participated between 24 Oct 2016 to 08 Feb 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | PyroTITAN™ HRA Shoulder System | Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intention to Treat (ITT) population included all participants implanted with available data available.
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| ID | Title | Description |
|---|---|---|
| BG000 | PyroTITAN™ HRA Shoulder System | Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) 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 | Device Survival: Kaplan-Meir Estimate | Device survival was defined as the absence of device fracture at the two year time-point. Percentage of participants with survival of the device estimated using the Kaplan-Meier method. | Participants with data available at the time frame indicated | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
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Surgery to end of study visit, up to 5 years
All postoperative device-related & surgery-related AEs reported. Specifically, all component removals (and/or revisions) whether device related or not were recorded. Other AEs may be classified as device-related (or non device-related) based on frequency, medical significance, & circumstance. An Adverse Event Monitoring Board (AEMB), in compliance with ISO 14155 standards, classified AE relatedness as separate findings.
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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 | PyroTITAN™ HRA Shoulder System | Participants implanted with PyroTITAN™ Humeral Resurfacing Arthroplasty (HRA) Shoulder System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right shoulder rotator cuff pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor rotator cuff tendonitis left shoulder. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manvendra Saxena | Senior Specialist-Clinical Study Management | +61 455 870 175 | manvendra.saxena@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2017 | Aug 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2023 | Aug 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year & five year time-points. |
| 2-Years and 5-Years |
| Cumulative Device Survival | Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year & five year time-points. | 2-Years and 5-Years |
| Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score | ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition. | Baseline, 2-Years and 5-Years |
| Device Functionality: Visual Analog Scale (VAS) - Pain | The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain. | Baseline, 2-Years and 5-Years |
| Device Functionality: Visual Analog Scale (VAS) - Satisfaction | The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result. | Baseline, 2-Years and 5-Years |
| Device Functionality: Western Ontario Osteoarthritis Score (WOOS) | The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome. | Baseline, 2-Years and 5-Years |
| Device Functionality: QuickDASH Outcome Measure | The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome. | Baseline, 2-Years and 5-Years |
| Device Functionality: Constant Murley Score (CMS) | The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome. | Baseline, 2-Years and 5-Years |
| Revision |
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| Death |
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| Participant did not return due to COVID-19 related lockdown |
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| Participant failed to return for follow-up visits |
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| Participant relocation |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dominant Side | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Secondary | Number of Participants With Device-Related Adverse Events | Count of participants with device-related Non-Serious & Serious Adverse Events were the event was related to device use (e.g., component breakage) as determined by investigator assessment. | Participants with data available at the time frame indicated | Posted | Count of Participants | Participants | Post-operatively to 5-Years |
|
|
|
| Secondary | Cumulative Device Success | Device success was defined as the absence of device fracture over time. Cumulative device success was determined by the percentage of participants with no device fractures by the two year & five year time-points. | Participants with data available at the time frame indicated | Posted | Number | 95% Confidence Interval | percentage of participants | 2-Years and 5-Years |
|
|
|
| Secondary | Cumulative Device Survival | Device survival was defined as the absence of device revision over time. Cumulative device survival was determined by the percentage of participants with no device revisions by the two year & five year time-points. | Participants with data available at the time frame indicated | Posted | Number | 95% Confidence Interval | percentage of participants | 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: American Shoulder and Elbow Surgeons (ASES) Score | ASES scores range from 0 to 100, with a score of 0 indicating a worse shoulder condition and 100 indicating the best shoulder condition. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: Visual Analog Scale (VAS) - Pain | The VAS Pain score range was from 0 to 100, with 0 representing no pain and 100 representing the worse possible pain. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: Visual Analog Scale (VAS) - Satisfaction | The VAS Satisfaction score range was from 0 to 100, with 0 representing the worst result and 100 representing the best result. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: Western Ontario Osteoarthritis Score (WOOS) | The WOOS score was based on 19 questions ranging from 0 to 100 with 0 being the best result and 100 being the worst result. A lower score indicated a better outcome. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: QuickDASH Outcome Measure | The QuickDASH (Disabilities of the Arm, Shoulder, and Hand) score ranged from 0 (no disability) to 100 (most severe disability) based on 11 questions scored 1 to 5 each (for disability/symptoms) and 4 questions scored 1 to 5 each (for performance/sport/work). A lower score indicates a better outcome. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| Secondary | Device Functionality: Constant Murley Score (CMS) | The Constant Murley Score (CMS) is a 100-point scale composed of individual parameters. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and Range of Motion (ROM) (40 points). Subscales are combined to indicate a total CMS score. The total CMS score ranges from 0 to 100 points, with higher scores indicating a better outcome. | Participants with data available at the time frame indicated | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-Years and 5-Years |
|
|
|
| 1 |
| 137 |
| 47 |
| 137 |
| 12 |
| 137 |
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| Right shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Duke C Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to Procedure or Device |
|
| Urosepsis following surgery for prostate cancer biopsy | Surgical and medical procedures | Systematic Assessment | Not related to Procedure or Device |
|
| Meniscus tear in left knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| cancerous nodule thyroid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to Procedure or Device |
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| Locking right knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
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| Fractured left scaphoid following a fall. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
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| worsening OA left knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Worsening of OA in right knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Back pain exacerbated | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Deterioration of left shoulder secondary to pre-existing condition (avacular necrosis). | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Thoracic outlet syndrome progression | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
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| Right shoulder rotator cuff impingement | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Right shoulder posterior instability | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Joint metallosis in right (operative) shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
|
| Right shoulder OA worsening | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Benign prostatic hyperplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to Procedure or Device |
|
| Cardiac chest pain | Cardiac disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Aggravation of OA in left thumb and wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Persistent right rotator cuff pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Anterior shoulder pain due to subscap impingement on the anterior aspect of the hemiarthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Fracture of PyroTITAN prosthesis. | Product Issues | Systematic Assessment | Device related |
|
| Cellulitis and recurring infection in right knee | Infections and infestations | Systematic Assessment | Not related to Procedure or Device |
|
| Left shoulder rotator cuff tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Broken right ankle | Injury, poisoning and procedural complications | Systematic Assessment | Not related to Procedure or Device |
|
| Undisplaced fracture of implant | Product Issues | Systematic Assessment | Device related |
|
| Worsening of OA in left shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Worsening knee OA and pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Difficulty with function and ROM in left operative shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Ongoing pain in left shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Right subscapular bursa irritation. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
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| Right shoulder full thickness tear | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Right leg cellulitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Rotator cuff tendonitis left shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Exacerbation of OA in right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Exacerabated right shoulder OA. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Cellulitis in left leg. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
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| Knife injury to left arm | Injury, poisoning and procedural complications | Systematic Assessment | Not related to Procedure or Device |
|
| Thoracic outlet syndrome progression. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Rotator cuff impingement left shoulder. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
|
| worsening osteoarthritis left wrist | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Exacerbation of OA right knee. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Subscapular bursa irritation left shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Procedure Related |
|
| Fractured prosthesis | Product Issues | Systematic Assessment | Device related |
|
| Worsening left shoulder osteoartritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Ongoing pain in right operative shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to Procedure or Device |
|
| worsening Osteoarthritis in right foot | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Worsening left shoulder osteoarthritis. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Worsening right shoulder arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Worsenning osteoarthritis bilateral knees. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
|
| Pneumonia | Infections and infestations | Systematic Assessment | Not related to Procedure or Device |
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| Exacerbation of lower back nerve pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Procedure or Device |
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| Infection left shoulder wound | Infections and infestations | Systematic Assessment | Procedure Related |
|
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| Suspected stress fracture of posterior glenoid osteophyte right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
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| Bursitis right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
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| Squeaking right shoulder after physiotherapy. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure or device |
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| Cuff pain right shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
|
| Suspected rotator cuff tendonitis left shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not relate to procedure or device |
|
| Suspected rotator cuff tendonitis right. | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure |
|
| Crepitation around right shoulder joint with activity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to Device |
|
| Occasional pain up right arm | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure or device |
|
| Audible squeaking left pyrotitan shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Audible squeak on flexion/extension of operative shoulder | Musculoskeletal and connective tissue disorders | Systematic Assessment | Device related |
|
| Persistent operative shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure or device |
|
| Skin irritation of scar in operative shoulder | Skin and subcutaneous tissue disorders | Systematic Assessment | Possibly related to procedure |
|
| right shoulder stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related to procedure or device |
|
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| 5-Years |
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| 5-Years |
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| 5-Years |
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| 5-Years |
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| 5-Years |
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| 5-Years |
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