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| Name | Class |
|---|---|
| Medartis AG | INDUSTRY |
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The objective of this study is to prospectively evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent double or triple arthrodesis using CCS screws.
This proposal is a collaborative effort of Medartis. This is a prospective investigation to evaluate the mid-term results and intraoperative and postoperative complication rate in patients who underwent subtalar,double or triple arthrodesis using CCS screws.The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Patients undergoing a double or triple arthrodesis in their foot using Aptus CCS screws will be asked to enroll in this study. After informed consent, the patients will be asked to complete the following patient reported outcomes questionnaires (standard of care for all patients in the Foot and Ankle section): VAS for pain, modified Coughlin rating scale, AOFAS, and FADI at each standard of care visit which includes preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years post operative. Patients will also receive standard of care radiographs at these visits, and a standard of care CT scan at 6 months.
Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Inclusion criteria include anyone over age 18 who has Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints, and/or Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction, and/or Neuromuscular disease mediated hindfoot deformities, and/or Tarsal coalitions, and/or Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot.and has failed nonoperative management. Typically, these patients have multiple medical comorbidities and therefore the only exclusion criteria will be patients who are not healthy enough to undergo surgery. Approximately 50 patients will be recruited for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 screws | Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 screws | Device | Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intraoperative Complications | All intraoperative complications including injury of neurovascular structures and/or tendons will be prospectively documented. All intraoperative technical difficulties (for example, breakage of the screw) will be prospectively documented. | At time of surgery |
| Number of Participants With Perioperative Complications | All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented. | Up to 2 years post-operative |
| Number of Participants With Delayed Osseous Union or Non-union | Independent radiologist will measure fusion of standard of care radiographs and CT scan | Up to 2 years post-operative |
| Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment | An independent radiologist will measure fusion of the double, triple, or subtalar fusion by reviewing the standard of care radiographs and CT scan and measuring the rate of fusion using the bridging of the trabecular bone. | Up to 2 years post-operative |
| Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | The VAS ranges from 0 (no pain) to 10 (maximal pain). | Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative |
| Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be identified in the clinic by an attending orthopaedic foot and ankle surgeon or his physician assistant based on clinical exam and radiographic findings. Patients of all racial, religious, and cultural backgrounds will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Mark E. Easley, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
Individual participant data will not be available. The results will be statistically analyzed as a whole.
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Two participants withdrew prior to surgery.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aptus CCS 5.0 or/and 7.0 Screws | Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aptus CCS 5.0 or/and 7.0 Screws | Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. |
| 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 |
| 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 | Number of Participants With Intraoperative Complications | All intraoperative complications including injury of neurovascular structures and/or tendons will be prospectively documented. All intraoperative technical difficulties (for example, breakage of the screw) will be prospectively documented. | Posted | Count of Participants | Participants | At time of surgery |
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Up to 2 years post-operative
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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 | Aptus CCS 5.0 or/and 7.0 Screws | Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant failure | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Breakdown | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Easley, M.D. | Duke University | 919-660-5066 | mark.e.easley@duke.edu |
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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 | Aug 31, 2021 | Jan 29, 2025 | Prot_SAP_000.pdf |
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The final score is the sum of the points across all 9 questions with a total score range of 0 to 28. A higher score indicates greater functionality.
| Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative |
| Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality. | Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative |
| Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal | All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented. | Up to 2 years post-operative |
| 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 (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Number of Participants With Perioperative Complications | All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented. | Posted | Count of Participants | Participants | Up to 2 years post-operative |
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| Primary | Number of Participants With Delayed Osseous Union or Non-union | Independent radiologist will measure fusion of standard of care radiographs and CT scan | Posted | Count of Participants | Participants | Up to 2 years post-operative |
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| Primary | Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment | An independent radiologist will measure fusion of the double, triple, or subtalar fusion by reviewing the standard of care radiographs and CT scan and measuring the rate of fusion using the bridging of the trabecular bone. | Data not collected due to infeasibility. | Posted | Up to 2 years post-operative |
|
|
| Primary | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | The VAS ranges from 0 (no pain) to 10 (maximal pain). | Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative |
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| Primary | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | The final score is the sum of the points across all 9 questions with a total score range of 0 to 28. A higher score indicates greater functionality. | Participants with data collected at each timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative |
|
|
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| Primary | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality. | Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected. | Posted | Mean | Standard Deviation | score on a scale | Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative |
|
|
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| Primary | Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal | All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented. | Posted | Count of Participants | Participants | Up to 2 years post-operative |
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| 2 |
| 48 |
| 8 |
| 48 |
| 26 |
| 48 |
| Deep vein thrombosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hardware Removal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Others | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| 6 months |
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| 1 year |
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| 2 years |
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| 6 months |
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| 1 year |
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| 2 years |
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| 6 months |
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| 1 year |
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| 2 years |
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