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

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.

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.