Post-traumatic Osteoarthritis, Unspecified Ankle and FootNCT02619838
Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
An observational study of Post-traumatic Osteoarthritis, Unspecified Ankle and Foot and Localized, Primary Osteoarthritis of the Ankle and/or Foot, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot
- What is being tested?
- Aptus CCS 5.0 or/and 7.0 screws
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2015to 29 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27703
About this study
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.
Read the 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.
- Conditions
- Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot
- Being tested
- Aptus CCS 5.0 or/and 7.0 screws
- Keywords
- Double Arthrodesis, Triple Arthrodesis, Subtalar Arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aptus CCS 5.0 or/and 7.0 screwsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Aptus CCS 5.0 or/and 7.0 screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start7 Oct 2015
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-traumatic Osteoarthritis, Unspecified Ankle and FootStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Medartis AG
- Responsible party
- Sponsor
- Investigators
- Mark E. Easley, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619838
- Sponsor's protocol ID
- Pro00059296
- Status last verified
- Mar 2025
- First submitted
- 15 Oct 2015
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be available. The results will be statistically analyzed as a whole.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
- ClinicalTrials.gov ID
- NCT02619838
- Acronym / sponsor ID
- Pro00059296
- Conditions
- Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot
- Keywords
- Double Arthrodesis, Triple Arthrodesis, Subtalar Arthrodesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Medartis AG
- Study start
- 7 Oct 2015 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 screws | – | Device: Aptus CCS 5.0 or/and 7.0 screwsProcedure/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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aptus CCS 5.0 or/and 7.0 screwsFusion 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. | Device | Aptus CCS 5.0 or/and 7.0 screws |
Primary outcome
Number of Participants With Intraoperative Complications
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 2 years post-operative
All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be available. The results will be statistically analyzed as a whole.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E. Easley, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-traumatic Osteoarthritis, Unspecified Ankle and Foot and Localized, Primary Osteoarthritis of the Ankle and/or Foot, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Intraoperative Complications (time frame: At time of surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.