Trial Outcomes & Findings for Prospective Subtalar, Double, or Triple Arthrodesis Study With CCS Screws (NCT NCT02619838)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

50 participants

Primary outcome timeframe

At time of surgery

Results posted on

2025-03-24

Participant Flow

Two participants withdrew prior to surgery.

Participant milestones

Participant milestones
Measure	Aptus CCS 5.0 or/and 7.0 Screws Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Overall Study STARTED	48
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Aptus CCS 5.0 or/and 7.0 Screws Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Overall Study Lost to Follow-up	9
Overall Study Withdrawal by Subject	15

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Age, Continuous	53 years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Number of Participants With Intraoperative Complications	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Number of Participants With Perioperative Complications	28 Participants

PRIMARY outcome

Timeframe: Up to 2 years post-operative

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

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Number of Participants With Delayed Osseous Union or Non-union	4 Participants

PRIMARY outcome

Timeframe: Up to 2 years post-operative

Population: Data not collected due to infeasibility.

An independent radiologist will measure fusion of the double, triple, or subtalar fusion by reviewing the standard of care radiographs and CT scan and measuring the rate of fusion using the bridging of the trabecular bone.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline (pre-operative), 3 months, 6 months, 1 year, and 2 years post-operative

Population: Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected.

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

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=50 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) Baseline	6.56 score on a scale Standard Deviation 2.65
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) 3 months	2.73 score on a scale Standard Deviation 2.60
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) 6 months	2.34 score on a scale Standard Deviation 2.40
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) 1 year	2.05 score on a scale Standard Deviation 2.58
Pain Following Double or Triple Arthrodesis as Measured by a Visual Analogue Scale (VAS) 2 years	2.47 score on a scale Standard Deviation 2.45

PRIMARY outcome

Timeframe: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative

Population: Participants with data collected at each timepoint.

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.

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=46 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score Baseline	18.74 score on a scale Standard Deviation 3.42
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score 3 months	17.60 score on a scale Standard Deviation 2.30
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score 6 months	15.38 score on a scale Standard Deviation 2.64
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score 1 year	13.65 score on a scale Standard Deviation 2.67
Functional Status Following Double or Triple Arthrodesis as Measured by the American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Score 2 years	14.71 score on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: Baseline (pre-operative), 6 weeks, 3 months, 6 months, 1 year, and 2 years post-operative

Population: Participants with data collected at each timepoint. Two participants withdrew prior to surgery, but had baseline data collected.

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

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=50 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score Baseline	49.02 score on a scale Standard Deviation 16.87
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score 3 months	47.00 score on a scale Standard Deviation 24.30
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score 6 months	70.67 score on a scale Standard Deviation 15.81
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score 1 year	75.76 score on a scale Standard Deviation 19.74
Functional Status Following Double or Triple Arthrodesis as Measured by the Foot & Ankle Disability Index (FADI) Score 2 years	78.44 score on a scale Standard Deviation 18.23

PRIMARY outcome

Timeframe: Up to 2 years post-operative

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

Outcome measures

Outcome measures
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 Participants Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Number of Participants With Secondary Surgical Procedures for Any Reason Including Hardware Removal	5 Participants

Adverse Events

Aptus CCS 5.0 or/and 7.0 Screws

Serious events: 8 serious events

Other events: 26 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 participants at risk Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Musculoskeletal and connective tissue disorders Implant failure	6.2% 3/48 • Up to 2 years post-operative
Musculoskeletal and connective tissue disorders Deep vein thrombosis	2.1% 1/48 • Up to 2 years post-operative
Musculoskeletal and connective tissue disorders Hardware Removal	10.4% 5/48 • Up to 2 years post-operative

Other adverse events

Other adverse events
Measure	Aptus CCS 5.0 or/and 7.0 Screws n=48 participants at risk Procedure/Surgery: Subtalar, Double or Triple Arthrodesis of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint of the foot with the Aptus CCS 5.0 or/and 7.0 screws Aptus CCS 5.0 or/and 7.0 screws: Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Musculoskeletal and connective tissue disorders Wound Breakdown	2.1% 1/48 • Up to 2 years post-operative
Musculoskeletal and connective tissue disorders Swelling	29.2% 14/48 • Up to 2 years post-operative
Musculoskeletal and connective tissue disorders Pain	18.8% 9/48 • Up to 2 years post-operative
Musculoskeletal and connective tissue disorders Others	31.2% 15/48 • Up to 2 years post-operative

Additional Information

Mark Easley, M.D.

Duke University

Phone: 919-660-5066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place