An observational study in Post-traumatic Osteoarthritis, Unspecified Ankle and Foot and Localized, Primary Osteoarthritis of the Ankle and/or Foot, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Duke University · Observational
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 50 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
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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.
Exclusion Criteria:
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
Device: 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.
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
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
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
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
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
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
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
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
| Milestone | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Started | 48 |
| Completed | 24 |
| Not completed | 24 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Withdrawal by subject | 15 |
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.
| Participants | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Number of Participants With Intraoperative Complications | 0 |
All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented.
| Participants | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Number of Participants With Perioperative Complications | 28 |
Independent radiologist will measure fusion of standard of care radiographs and CT scan
| Participants | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Number of Participants With Delayed Osseous Union or Non-union | 4 |
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.
No measurements were reported for this outcome.
The VAS ranges from 0 (no pain) to 10 (maximal pain).
| score on a scale | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Baseline | 6.56 ± 2.65 |
| 3 months | 2.73 ± 2.60 |
| 6 months | 2.34 ± 2.40 |
| 1 year | 2.05 ± 2.58 |
| 2 years | 2.47 ± 2.45 |
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.
| score on a scale | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Baseline | 18.74 ± 3.42 |
| 3 months | 17.60 ± 2.30 |
| 6 months | 15.38 ± 2.64 |
| 1 year | 13.65 ± 2.67 |
| 2 years | 14.71 ± 2.20 |
The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality.
| score on a scale | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Baseline | 49.02 ± 16.87 |
| 3 months | 47.00 ± 24.30 |
| 6 months | 70.67 ± 15.81 |
| 1 year | 75.76 ± 19.74 |
| 2 years | 78.44 ± 18.23 |
All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented.
| Participants | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal | 5 |
Collected over Up to 2 years post-operative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aptus CCS 5.0 or/and 7.0 Screws | 2/48 (4.2%) | 8/48 (16.7%) | 26/48 (54.2%) |
| Event | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Hardware RemovalMusculoskeletal and connective tissue disorders | 5/48 |
| Implant failureMusculoskeletal and connective tissue disorders | 3/48 |
| Deep vein thrombosisMusculoskeletal and connective tissue disorders | 1/48 |
| Event | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| OthersMusculoskeletal and connective tissue disorders | 15/48 |
| SwellingMusculoskeletal and connective tissue disorders | 14/48 |
| PainMusculoskeletal and connective tissue disorders | 9/48 |
| Wound BreakdownMusculoskeletal and connective tissue disorders | 1/48 |
| Age, Continuous(years) | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Mean | 53 ± 15.5 |
| Sex: Female, Male(Participants) | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Female | 27 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 48 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 41 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Aptus CCS 5.0 or/and 7.0 Screws |
|---|---|
| United States | 48 |
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Plan to share: No — Individual participant data will not be available. The results will be statistically analyzed as a whole.
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