Trial Outcomes & Findings for Compression Nail for Tibiocalcaneal Arthrodesis (NCT NCT03780452)

NCT ID: NCT03780452

Last Updated: 2025-05-31

Results Overview

Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.

• Recruitment status: COMPLETED
• Target enrollment: 13 participants
• Primary outcome timeframe: 0 - 12 months postoperatively
• Results posted on: 2025-05-31

Participant Flow

Patients were recruited if they met the indications for tibiotalocalcaneal arthrodesis, were able to understand the requirements of the study, provide a written consent, and were willing to comply with the study protocol, and were over 18 years of age. Patients were recruited between 2020 and 2023 at an Orthopedic Clinic at a busy urban medical center.

Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1 year post-operatively

Participant milestones

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Tibiotalocalcaneal Arthrodesis With DynaNail Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel

Overall Study Screening failure

2

Baseline Characteristics

Compression Nail for Tibiocalcaneal Arthrodesis

Baseline characteristics by cohort

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail n=11 Participants Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	10 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
Body Mass Index (BMI) BMI < 30	3 Participants n=5 Participants
Body Mass Index (BMI) BMI > = 30	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 - 12 months postoperatively

Population: Patients having undergone tibiotalocalcaneal arthrodesis with completion of Visual Analog Scale surveys

Visual Analog Scale (VAS). Patients will disclose their pain level using the Visual Analog Scale, which measures pain on a scale of 0 - 100, with 0 indicating no pain and 100 indicating severe pain.

Outcome measures

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail n=11 Participants Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel
Pain Assessment Baseline	52.73 score on a scale Standard Deviation 22.60
Pain Assessment 2 Weeks	33.00 score on a scale Standard Deviation 30.35
Pain Assessment 6 Weeks	17.00 score on a scale Standard Deviation 26.19
Pain Assessment 12 Weeks	21.25 score on a scale Standard Deviation 26.19
Pain Assessment 24 Weeks	20.00 score on a scale Standard Deviation 15.11
Pain Assessment 1 Year	34.00 score on a scale Standard Deviation 25.77

PRIMARY outcome

Timeframe: 0 - 12 months postoperatively

Population: Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail who completed their Foot and Ankle Ability Measure surveys.

Foot and Ankle Ability Measure (FAAM). The FAAM is made up of a 21-item activity of daily living (ADL) and and 8-item sports subscale, which are combined to form a single total score. The ADL subscale ranges from 0 to 84 and the sports from 0 to 32. The total score is a calculated by adding the two subscores together and then reporting as a percentage of the total possible score (116). The percent score range is from 0% to 100%. For interpretation of the results a score closure to 100% is considered greater function.

Outcome measures

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail n=11 Participants Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel
Functional Assessment Baseline	48.18 percentage of total score Standard Deviation 36.32
Functional Assessment 2 Weeks	42.27 percentage of total score Standard Deviation 60.95
Functional Assessment 6 Weeks	14.55 percentage of total score Standard Deviation 16.53
Functional Assessment 12 Weeks	56.00 percentage of total score Standard Deviation 50.79
Functional Assessment 24 Weeks	77.85 percentage of total score Standard Deviation 60.29
Functional Assessment 1 Year	53.5 percentage of total score Standard Deviation 3.5

PRIMARY outcome

Timeframe: 0 - 12 months postoperatively

Population: Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail who completed their Short Form 36 surveys.

The Short Form 36 (SF-36) is a total of 36 questions covering 8 domains of health: (1) limitations in physical activities, (2) limitations in social activities, (3) limitations in usual role activities due to physical health problems, (4) bodily pain, (5) general mental health, (6) Limitations in usual role activities due to emotional problems, (7) Vitality, and (8) General health perceptions. The domain scores are added together for a total score. The total is a reported as a percentage from 0% to 100% with 50 serving as the normative value. Higher scores represent a greater level of functioning.

Outcome measures

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail n=11 Participants Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel
Change in Functional Assessment Baseline	24.74 percentage of total score Standard Deviation 12.78
Change in Functional Assessment 2 Weeks	23.82 percentage of total score Standard Deviation 12.25
Change in Functional Assessment 6 Weeks	27.46 percentage of total score Standard Deviation 15.00
Change in Functional Assessment 12 Weeks	37.64 percentage of total score Standard Deviation 9.68
Change in Functional Assessment 24 Weeks	40.56 percentage of total score Standard Deviation 12.64
Change in Functional Assessment 1 Year	39.64 percentage of total score Standard Deviation 8.73

PRIMARY outcome

Timeframe: 0 - 12 months postoperative

Population: Patients analyzed include those that underwent tibiotalocalcaneal arthrodesis with a Dynamic Compression Intramedullary Nail with post-operative imaging.

radiographs taken Pre-operatively, 2 weeks, 4 weeks, 6 weeks, 3 Months, 6 Months, 12 Months and 24 Months. A CT scan will be done at 6 months.

Outcome measures

Measure	Tibiotalocalcaneal Arthrodesis With DynaNail n=8 Participants Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel
Fusion, as Measured by Radiograph and CT Scan Union	7 Participants
Fusion, as Measured by Radiograph and CT Scan Nonunion	1 Participants
Fusion, as Measured by Radiograph and CT Scan Malunion	0 Participants

Adverse Events

Tibiotalocalcaneal Arthrodesis With DynaNail

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure

Tibiotalocalcaneal Arthrodesis With DynaNail n=11 participants at risk Tibiotalocalcaneal arthrodesis with a novel dynamic compression intramedullary nail novel dynamic compression intramedullary nail: Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator. Patients were screened for those scheduled to undergo a tibiotalocalcaneal arthrodesis at an ambulatory surgery center with one of the participating foot and ankle fellowship trained orthopaedic surgeons. Patients enrolled in the study had their surgery performed with a Dynamic compression Intramedullary Nail with the aim of improved function and pain. Follow-up occurred in clinic and via surveys pre-operatively, as well as, 2-weeks, 6-weeks, 12-weeks, 24-weeks, and 1-year post-operativel

Product Issues Implant Failure

27.3% 3/11 • 0-12 months post-operative

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ashish Shah

UAB Department of Orthopaedic Surgery

Phone: (205) 930-8339

Email: ashishshah@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place