N/A
N=48
Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws
Post-traumatic Osteoarthritis, Unspecified Ankle and Foot · Localized, Primary Osteoarthritis of the Ankle and/or Foot
Bottom Line
View on ClinicalTrials.gov: NCT02619838 ↗Enrolled (actual)
48
Serious AEs
16.7%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Intraoperative Complications — 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Aptus CCS 5.0 or/and 7.0 screws (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Intraoperative Complications |
— | — |
| PRIMARY Number of Participants With Perioperative Complications |
28 | — |
| PRIMARY Number of Participants With Delayed Osseous Union or Non-union |
4 | — |
| PRIMARY Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment |
— | — |
| PRIMARY Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) |
6.56; 2.73; 2.34; 2.05; 2.47 | — |
| PRIMARY Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score |
18.74; 17.60; 15.38; 13.65; 14.71 | — |
| PRIMARY Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score |
49.02; 47.00; 70.67; 75.76; 78.44 | — |
| PRIMARY Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal |
5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02619838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.