Clinical trial NCT02619838: Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
Official title: Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-traumatic Osteoarthritis, Unspecified Ankle and Foot
Localized, Primary Osteoarthritis of the Ankle and/or Foot
Keywords: Double Arthrodesis
Triple Arthrodesis
Subtalar Arthrodesis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Medartis AG
First posted: 2015-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Intraoperative Complications
timeFrame: At time of surgery
measure: Number of Participants With Perioperative Complications
timeFrame: Up to 2 years post-operative
measure: Number of Participants With Delayed Osseous Union or Non-union
timeFrame: Up to 2 years post-operative
measure: Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment
timeFrame: Up to 2 years post-operative
measure: Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS)
timeFrame: Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative
measure: Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score
timeFrame: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
measure: Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score
timeFrame: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative
measure: Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal
timeFrame: Up to 2 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Mark E. Easley, MD
role: PRINCIPAL_INVESTIGATOR
References: