Localized, Primary Osteoarthritis of the Ankle and/or Foot, Post-traumatic Osteoarthritis, Unspecified Ankle and Foot
Conditions
Keywords
Double Arthrodesis, Triple Arthrodesis, Subtalar Arthrodesis
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAptus 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.
Sponsors
Medartis AG
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Rheumatoid or posttraumatic osteoarthritis of the hindfoot with involvement of subtalar, talonavicular, and calcaneocuboid joints (2;12). * Symptomatic rigid pes planovalgus et abductus with end-stage posterior tibial tendon dysfunction (e.g. grade IV) (4;13-15). * Neuromuscular disease mediated hindfoot deformities (16). * Tarsal coalitions (17). * Indication for calcaneocuboid arthrodesis: severe degenerative changes in the calcaneocuboid joint and/or severe abductus deformity of the forefoot. * Between the age 18-75
Exclusion criteria
* Acute or chronic infection. * Poor vascular status of the lower leg (relative contraindication for double arthrodesis through a single medial approach). * Women that are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intraoperative Complications | At time of surgery | 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. |
| Number of Participants With Perioperative Complications | Up to 2 years post-operative | All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented. |
| Number of Participants With Delayed Osseous Union or Non-union | Up to 2 years post-operative | Independent radiologist will measure fusion of standard of care radiographs and CT scan |
| Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment | Up to 2 years post-operative | 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. |
| Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative | The VAS ranges from 0 (no pain) to 10 (maximal pain). |
| Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative | 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. |
| Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative | The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality. |
| Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal | Up to 2 years post-operative | All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented. |
Countries
United States
Participant flow
Pre-assignment details
Two participants withdrew prior to surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Region of Enrollment United States | 48 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 48 |
| other Total, other adverse events | 26 / 48 |
| serious Total, serious adverse events | 8 / 48 |
Outcome results
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.
Time frame: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
Population: Participants with data collected at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | Baseline | 18.74 score on a scale | Standard Deviation 3.42 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | 3 months | 17.60 score on a scale | Standard Deviation 2.3 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | 6 months | 15.38 score on a scale | Standard Deviation 2.64 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | 1 year | 13.65 score on a scale | Standard Deviation 2.67 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score | 2 years | 14.71 score on a scale | Standard Deviation 2.2 |
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.
Time frame: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
Population: Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | Baseline | 49.02 score on a scale | Standard Deviation 16.87 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | 3 months | 47.00 score on a scale | Standard Deviation 24.3 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | 6 months | 70.67 score on a scale | Standard Deviation 15.81 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | 1 year | 75.76 score on a scale | Standard Deviation 19.74 |
| Aptus CCS 5.0 or/and 7.0 Screws | Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score | 2 years | 78.44 score on a scale | Standard Deviation 18.23 |
Primary
Number of Participants With Delayed Osseous Union or Non-union
Independent radiologist will measure fusion of standard of care radiographs and CT scan
Time frame: Up to 2 years post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Number of Participants With Delayed Osseous Union or Non-union | 4 Participants |
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.
Time frame: Up to 2 years post-operative
Population: Data not collected due to infeasibility.
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.
Time frame: At time of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Number of Participants With Intraoperative Complications | 0 Participants |
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.
Time frame: Up to 2 years post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Number of Participants With Perioperative Complications | 28 Participants |
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.
Time frame: Up to 2 years post-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal | 5 Participants |
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).
Time frame: Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative
Population: Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | 1 year | 2.05 score on a scale | Standard Deviation 2.58 |
| Aptus CCS 5.0 or/and 7.0 Screws | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | 2 years | 2.47 score on a scale | Standard Deviation 2.45 |
| Aptus CCS 5.0 or/and 7.0 Screws | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | Baseline | 6.56 score on a scale | Standard Deviation 2.65 |
| Aptus CCS 5.0 or/and 7.0 Screws | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | 3 months | 2.73 score on a scale | Standard Deviation 2.6 |
| Aptus CCS 5.0 or/and 7.0 Screws | Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) | 6 months | 2.34 score on a scale | Standard Deviation 2.4 |