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

NCT ID: NCT02619838

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-07
• Study Completion Date: 2024-01-29

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.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medartis AG

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark E. Easley, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00059296

Identifier Type: -

Identifier Source: org_study_id