Trial Outcomes & Findings for A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor (NCT NCT04186481)
NCT ID: NCT04186481
Last Updated: 2021-02-26
Results Overview
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
6 months
Results posted on
2021-02-26
Participant Flow
The enrollment of this retrospective study was conducted between 25 Oct 2019 and 08 Nov 2019. 32 subjects were enrolled into the study at 1 site. All 32 subjects enrolled completed the study, of which, 31 subjects completed the 6-month visit, and 4 subjects completed the 12-month visit.
Participant milestones
| Measure |
Minitac Ti 2.0 Suture Anchor
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Completed 6 Month Visit
|
31
|
|
Overall Study
Completed 12 Month Visit
|
4
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
Baseline characteristics by cohort
| Measure |
Minitac Ti 2.0 Suture Anchor
n=32 Participants
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
32 participants
n=5 Participants
|
|
Height
|
172.19 cm
STANDARD_DEVIATION 10.52 • n=5 Participants
|
|
Weight
|
83.93 kg
STANDARD_DEVIATION 24.14 • n=5 Participants
|
|
Body Mass Index
|
28.11 kg/m^2
STANDARD_DEVIATION 6.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor. The FAS was used for all analyses. The overall number of participants analyzed includes all participants that completed the 6 month visit.
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
Outcome measures
| Measure |
Minitac Ti 2.0 Suture Anchor
n=31 Participants
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
|
31 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor. The FAS was used for all analyses. The overall number of participants analyzed includes all participants that completed the 12 month visit.
Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit
Outcome measures
| Measure |
Minitac Ti 2.0 Suture Anchor
n=4 Participants
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 and 12 monthsPopulation: The Full Analysis Set (FAS) included all subjects enrolled in the study who had previously undergone open or arthroscopic surgery for extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor. The FAS was used for all analyses. The number of participants analyzed for each time frame includes all participants that completed the 6 or 12 month visit.
Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits
Outcome measures
| Measure |
Minitac Ti 2.0 Suture Anchor
n=31 Participants
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Range of Motion (ROM)
6 months - has full functional arc · Yes
|
6 Participants
|
|
Range of Motion (ROM)
6 months - has full functional arc · No
|
25 Participants
|
|
Range of Motion (ROM)
12 months - has full functional arc · Yes
|
1 Participants
|
|
Range of Motion (ROM)
12 months - has full functional arc · No
|
3 Participants
|
Adverse Events
Minitac Ti 2.0 Suture Anchor
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minitac Ti 2.0 Suture Anchor
n=32 participants at risk
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Quervain's tenosynovitis
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
Other adverse events
| Measure |
Minitac Ti 2.0 Suture Anchor
n=32 participants at risk
Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor
MINITAC Ti 2.0 suture anchor: The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Bilateral MCP Joint Pain, diagnosed as Arthritis by X-ray
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Dequervains Tensynovitis
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Development of Small Dupuytrens Cord at level of scar over MCP joint
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
General disorders
Increased Pain
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
K-wire Migration
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Lucency around Bone anchor as evidenced on X-ray
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Mild Subluxation of Metacarpophalangeal (MCP) Joint
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Moisture with mild Erythema to surgical wound
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Neuropaxia around scar
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Pain and numbness to right thumb and radial three digits
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Superficial infection around wire site.
|
3.1%
1/32 • Number of events 1 • All adverse events (AEs) and complications were collected to the extent they were available in the medical record. AE data were collected at the following timepoints: Screening - AEs from enrolment until discharge from hospital, including intraoperative complications 6 Months - AEs from discharge until 6 months follow-up 12 Months - AEs from 6 months until 12 months follow-up
|
Additional Information
Alison Walker, Regional Operation Manager ANZ
Smith+Nephew, Inc.
Phone: +61 466 322 200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60