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Completed

NCT Number: NCT02619838

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center

Durham, North Carolina, 27703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medartis AG

Registry information

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2015
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.