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

Completed

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

Interventions: Device: Aptus CCS 5.0 or/and 7.0 screws

Registration Number: NCT02619838

Lead Sponsor: Duke University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aptus CCS 5.0 or/and 7.0 screws	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Intraoperative Complications	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.
Number of Participants With Perioperative Complications	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.
Number of Participants With Delayed Osseous Union or Non-union	Up to 2 years post-operative	Independent radiologist will measure fusion of standard of care radiographs and CT scan
Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal	Up to 2 years post-operative	All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented.
Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment	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.
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS)	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).
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score	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.
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score	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.