Who is sponsoring NCT02619838?

NCT02619838 is sponsored by Duke University.

What drugs are being tested in NCT02619838?

Interventions in NCT02619838: Aptus CCS 5.0 or/and 7.0 screws.

What condition does NCT02619838 study?

NCT02619838 studies Post-traumatic Osteoarthritis, Unspecified Ankle and Foot, Localized, Primary Osteoarthritis of the Ankle and/or Foot.

Is NCT02619838 still recruiting?

NCT02619838 is currently completed. Last updated 24 March 2025.

Are results published for NCT02619838?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-24 · How we verify

NCT02619838

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 24 March 2025

What this trial tests

trial testing Aptus CCS 5.0 or/and 7.0 screws in Post-traumatic Osteoarthritis, Unspecified Ankle and Foot in 50 participants. Completed in 29 January 2024.

Timeline

7 October 2015

Primary endpoint
29 January 2024

29 January 2024

Quick facts

Lead sponsor	Duke University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	50
Start date	7 October 2015
Primary completion	29 January 2024
Estimated completion	29 January 2024
Sites	1 location across United States

Drugs / interventions tested

Aptus CCS 5.0 or/and 7.0 screws

Conditions studied

Post-traumatic Osteoarthritis, Unspecified Ankle and Foot — all drugs for Post-traumatic Osteoarthritis, Unspecified Ankle and Foot →
Localized, Primary Osteoarthritis of the Ankle and/or Foot — all drugs for Localized, Primary Osteoarthritis of the Ankle and/or Foot →

Sponsor

Duke University

Who can join

Adults 18 to 75, any sex, with Post-traumatic Osteoarthritis, Unspecified Ankle and Foot or Localized, Primary Osteoarthritis of the Ankle and/or Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Intraoperative Complications Primary · At time of surgery

All intraoperative complications including injury of neurovascular structures and/or tendons will be prospectively documented. All intraoperative technical difficulties (for example, breakage of the screw) will be prospectively documented.

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	0

Number of Participants With Perioperative Complications Primary · Up to 2 years post-operative

All perioperative complications including wound healing problems and/or superficial/deep infection and/or deep vein thrombosis will be prospectively documented.

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	28

Number of Participants With Delayed Osseous Union or Non-union Primary · Up to 2 years post-operative

Independent radiologist will measure fusion of standard of care radiographs and CT scan

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	4

Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) Primary · Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative

The VAS ranges from 0 (no pain) to 10 (maximal pain).

Baseline

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	6.56	± 2.65

3 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	2.73	± 2.60

6 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	2.34	± 2.40

1 year

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	2.05	± 2.58

2 years

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	2.47	± 2.45

Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score Primary · Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative

The final score is the sum of the points across all 9 questions with a total score range of 0 to 28. A higher score indicates greater functionality.

Baseline

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	18.74	± 3.42

3 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	17.60	± 2.30

6 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	15.38	± 2.64

1 year

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	13.65	± 2.67

2 years

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	14.71	± 2.20

Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score Primary · Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative

The FADI has a total score range of 0 to 104, where a higher score indicates greater functionality.

Baseline

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	49.02	± 16.87

3 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	47.00	± 24.30

6 months

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	70.67	± 15.81

1 year

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	75.76	± 19.74

2 years

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	78.44	± 18.23

Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal Primary · Up to 2 years post-operative

All postoperative complications requiring any secondary surgical procedures including hardware removal will be prospectively documented.

Group	Value	95% CI
Aptus CCS 5.0 or/and 7.0 Screws	5

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years post-operative. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aptus CCS 5.0 or/and 7.0 Screws

Serious: 8/48 (17%)

Deaths: 2/48

Serious adverse events (3 terms)

Reaction	System	Aptus CCS 5.0 or/and 7.0 S…
Hardware Removal	Musculoskeletal and connective tissue disorders	—
Implant failure	Musculoskeletal and connective tissue disorders	—
Deep vein thrombosis	Musculoskeletal and connective tissue disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	Aptus CCS 5.0 or/and 7.0 S…
Others	Musculoskeletal and connective tissue disorders	—
Swelling	Musculoskeletal and connective tissue disorders	—
Pain	Musculoskeletal and connective tissue disorders	—
Wound Breakdown	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Hardware Removal, Implant failure, Deep vein thrombosis.

Data from ClinicalTrials.gov NCT02619838 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02619838 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Duke University
Last refreshed: 24 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02619838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02619838

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (3 terms)

Sponsor's own description

Publications & conference data

Related trials

Other Duke University trials

Verify against primary sources