Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
Condition: Post-traumatic Osteoarthritis, Unspecified Ankle and Foot; Localized, Primary Osteoarthritis of the Ankle and/or Foot
MeSH terms: Osteoarthritis
Study type: Observational

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.
    

Intervention name(s): Aptus CCS 5.0 or/and 7.0 screws
Intervention type(s): Device
Intervention description(s): 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.
Observational model: Case-Only
Time perspective: Prospective
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.
      
Keywords: Double Arthrodesis; Triple Arthrodesis; Subtalar Arthrodesis