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