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

Localized, Primary Osteoarthritis of the Ankle and/or Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619838
• Other study ID #: Pro00059296
• Status: Completed
• Start date: October 7, 2015
• Est. completion date: January 29, 2024

Study information

• Verified date: May 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 29, 2024
• Est. primary completion date: January 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Medartis AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	The double or triple arthrodesis in substantial pain relief	VAS	Pre-operative to 2 years post operative
Primary	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
Primary	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
Primary	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