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This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.
Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minitac Ti 2.0 suture anchor | Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINITAC Ti 2.0 suture anchor | Device | The MINITACâ—Š Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate (%) of the MINITACâ—Š Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success Rate (%) of the MINITACâ—Š Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Range of Motion (ROM) | Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits | 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc) | Maitland Hand and Othopaedic surgery | Principal Investigator |
| Stephan Mangin | Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maitland Hand and Othopaedic surgery | Ashtonfield | New South Wales | 2323 | Australia |
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The enrollment of this retrospective study was conducted between 25 Oct 2019 and 08 Nov 2019. 32 subjects were enrolled into the study at 1 site. All 32 subjects enrolled completed the study, of which, 31 subjects completed the 6-month visit, and 4 subjects completed the 12-month visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minitac Ti 2.0 Suture Anchor | Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor MINITAC Ti 2.0 suture anchor: The MINITACâ—Š Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 4, 2019 | Nov 20, 2020 |
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| Completed 6 Month Visit |
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| Completed 12 Month Visit |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Minitac Ti 2.0 Suture Anchor | Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor MINITAC Ti 2.0 suture anchor: The MINITACâ—Š Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| 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 | Clinical Success Rate (%) of the MINITACâ—Š Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon. | The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITACâ—Š Ti 2.0 Suture Anchor. The FAS was used for all analyses. The overall number of participants analyzed includes all participants that completed the 6 month visit. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Clinical Success Rate (%) of the MINITACâ—Š Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit | The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITACâ—Š Ti 2.0 Suture Anchor. The FAS was used for all analyses. The overall number of participants analyzed includes all participants that completed the 12 month visit. | Posted | Count of Participants | Participants | 12 months |
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| Other Pre-specified | Range of Motion (ROM) | Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits | The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITACâ—Š Ti 2.0 Suture Anchor. The FAS was used for all analyses. The number of participants analyzed for each time frame includes all participants that completed the 6 or 12 month visit. | Posted | Count of Participants | Participants | 6 and 12 months |
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All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
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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 | Minitac Ti 2.0 Suture Anchor | Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor MINITAC Ti 2.0 suture anchor: The MINITACâ—Š Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand. | 0 | 32 | 1 | 32 | 8 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Quervain's tenosynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilateral MCP Joint Pain, diagnosed as Arthritis by X-ray | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dequervains Tensynovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Development of Small Dupuytrens Cord at level of scar over MCP joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Increased Pain | General disorders | Non-systematic Assessment |
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| K-wire Migration | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Lucency around Bone anchor as evidenced on X-ray | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Mild Subluxation of Metacarpophalangeal (MCP) Joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MCP Joint Mildly Subluxed With Condral Loss With The Head Of The Proximal Phalanx Rubbing Against The Head Of The Metacarpal- Left Hand |
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| Moisture with mild Erythema to surgical wound | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Neuropaxia around scar | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain and numbness to right thumb and radial three digits | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Superficial infection around wire site. | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Due to the nature of the study design, retrospective data was collected to the extent it was available.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Walker, Regional Operation Manager ANZ | Smith+Nephew, Inc. | +61 466 322 200 | Alison.walker@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2020 | Jan 20, 2021 | SAP_001.pdf |
| Unknown or Not Reported |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Multiple |
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| Not Reported |
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| Unknown |
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