CompletedNot Applicable

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

United States50 participantsStarted 2015-10-07

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Intraoperative Complications

Timeframe: At time of surgery

Number of Participants With Perioperative Complications

Timeframe: Up to 2 years post-operative

Number of Participants With Delayed Osseous Union or Non-union

Timeframe: Up to 2 years post-operative

Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment

Timeframe: Up to 2 years post-operative

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

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

Trial details

NCT IDNCT02619838

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-29

Results submitted2025-01-29

View on ClinicalTrials.gov More Post-traumatic Osteoarthritis, Unspecified Ankle and Foot trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants With Intraoperative Complications

Timeframe: At time of surgery

Number of Participants With Perioperative Complications

Timeframe: Up to 2 years post-operative

Number of Participants With Delayed Osseous Union or Non-union

Timeframe: Up to 2 years post-operative

Number of Participants With Fixation of a Double or Triple Arthrodesis Neutral Hindfoot Alignment

Timeframe: Up to 2 years post-operative

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

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