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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Osteoarthritis, Unspecified Ankle and Foot; Localized, Primary Osteoarthritis of the Ankle and/or Foot
• Intervention / Treatment: Device: Aptus CCS 5.0 or/and 7.0 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of 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. The rate of the intraoperative complications will be calculated by an independent observer.	Surgery
The rate of perioperative complications.	All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented. The rate of the perioperative complications will be calculated by an independent observer.	Surgery up to 2 years post operative.
The rate of delayed osseous union or non-union.	Independent radiologist will measure fusion of standard of care radiographs and CT scan	Surgery up to 2 years post operative
The 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.	Surgery up to 2 years post operative
The double or triple arthrodesis in substantial pain relief	VAS	Pre-operative to 2 years post operative
The double or triple arthrodesis will result in substantial functional improvement, as measured by the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score	The functional status will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score and Foot & Ankle Disability Index (FADI) score preoperatively and postoperatively at all follow-ups 6 weeks, 3 months, 6 months, 1 year, and 2 years.	Pre-operative to 2 years post operative
The double or triple arthrodesis will result in substantial functional improvement, as measured by the Foot & Ankle Disability Index (FADI) score	The functional status will be assessed using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score and Foot & Ankle Disability Index (FADI) score preoperatively and postoperatively at all follow-ups 6 weeks, 3 months, 6 months, 1 year, and 2 years.	Pre-operative to 2 years post operative
The rate of secondary surgical procedures for any reason including hardware removal	All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented. The rate of the perioperative complications will be calculated by an independent observer.	Surgery up to 2 years post operative

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Medartis AG
• Investigators: Principal Investigator: Mark E. Easley, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2015
• Primary Completion (Actual): January 29, 2024
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: October 15, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimated): December 2, 2015

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Subtalar Arthrodesis; Double Arthrodesis; Triple Arthrodesis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Pro00059296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available. The results will be statistically analyzed as a whole.