Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws

NCT02619838 | Completed Results

• 1 other identifier: Pro00059296
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-traumatic Osteoarthritis, Unspecified Ankle and Foot; Localized, Primary Osteoarthritis of the Ankle and/or Foot

Keywords

Double Arthrodesis; Triple Arthrodesis; Subtalar Arthrodesis

Outcome Measures

Primary Outcomes (8)

• 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

  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

Study Arms (1)

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

Device: Aptus CCS 5.0 or/and 7.0 screws

Interventions

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.

Aptus CCS 5.0 or/and 7.0 screws

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Medartis AG: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27703, United States

Location

Results Point of Contact

• Title: Mark Easley, M.D.
• Organization: Duke University

mark.e.easley@duke.edu

919-660-5066

Study Officials

• Mark E. Easley, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: December 2, 2015
• Study Start: October 7, 2015
• Primary Completion: January 29, 2024
• Study Completion: January 29, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)