A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor

• Sponsor: Smith & Nephew, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04186481
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Actual Duration (Days): 14
• Patients Per Site Per Month: 69.6

Study Details

Study Description

Brief Summary

This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus Repairs; Medial or Lateral Instability Repairs/Reconstructions; Achilles Tendon Repairs/Reconstructions; Midfoot Reconstructions; Metatarsal Ligament/Tendon Repairs/Reconstructions; Scapholunate Ligament Reconstructions; Ulnar or Radial Collateral Ligament Reconstructions; Lateral Epicondylitis Repair; Biceps Tendon Reattachment	Device: MINITAC Ti 2.0 suture anchor

Detailed Description

Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Study Design

• Study Type: Observational
• Actual Enrollment: 32 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
• Actual Study Start Date: Oct 25, 2019
• Actual Primary Completion Date: Nov 8, 2019
• Actual Study Completion Date: Nov 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Minitac Ti 2.0 suture anchor Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative [6 months]

   Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.

Secondary Outcome Measures

1. Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative [12 months]

   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

Other Outcome Measures

1. Range of Motion (ROM) [6 and 12 months]

   Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.

2. Subject was ≥ 18 years of age at time of surgery.

3. Subject status is > 12 months post-operative.

Exclusion Criteria:

Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maitland Hand and Othopaedic surgery	Ashtonfield	New South Wales	Australia	2323

Sponsors and Collaborators

• Smith & Nephew, Inc.

Investigators

• Principal Investigator: Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc), Maitland Hand and Othopaedic surgery
• Study Chair: Stephan Mangin, Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew

Study Documents (Full-Text)

• Study Protocol - Sep 4, 2019
• Statistical Analysis Plan - Dec 10, 2020

More Information

Publications

None provided.

• Responsible Party: Smith & Nephew, Inc.
• ClinicalTrials.gov Identifier: NCT04186481
• Other Study ID Numbers: MINI.PMCF.2018.11
• First Posted: Dec 4, 2019
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tennis Elbow; Hallux Valgus

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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.
Period Title: Overall Study
STARTED	32
Completed 6 Month Visit	31
Completed 12 Month Visit	4
COMPLETED	32
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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 Participants	32
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.8 (14.06)
Sex: Female, Male (Count of Participants)
Female	15 46.9%
Male	17 53.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	0 0%
Unknown or Not Reported	32 100%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Black or African American	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
White	0 0%
Other	32 100%
Multiple	0 0%
Not Reported	0 0%
Unknown	0 0%
Region of Enrollment (participants) [Number]
Australia	32 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	172.19 (10.52)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	83.93 (24.14)
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.11 (6.42)

Outcome Measures

1. Primary Outcome

Title	Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
Description	Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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.
Measure Participants	31
Count of Participants [Participants]	31 96.9%

2. Secondary Outcome

Title	Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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.
Measure Participants	4
Count of Participants [Participants]	4 12.5%

3. Other Pre-specified Outcome

Title	Range of Motion (ROM)
Description	Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits
Time Frame	6 and 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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.
Measure Participants	31
Yes	6 18.8%
No	25 78.1%
Yes	1 3.1%
No	3 9.4%

Adverse Events

Time Frame	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
Arm/Group Title	Minitac Ti 2.0 Suture Anchor
Arm/Group Description	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.
All Cause Mortality
	Minitac Ti 2.0 Suture Anchor
	Affected / at Risk (%)	# Events
Total	0/32 (0%)
Serious Adverse Events
	Minitac Ti 2.0 Suture Anchor
	Affected / at Risk (%)	# Events
Total	1/32 (3.1%)
Musculoskeletal and connective tissue disorders
Quervain's tenosynovitis	1/32 (3.1%)	1
Other (Not Including Serious) Adverse Events
	Minitac Ti 2.0 Suture Anchor
	Affected / at Risk (%)	# Events
Total	8/32 (25%)
General disorders
Increased Pain	1/32 (3.1%)	1
Musculoskeletal and connective tissue disorders
Bilateral MCP Joint Pain, diagnosed as Arthritis by X-ray	1/32 (3.1%)	1
Dequervains Tensynovitis	1/32 (3.1%)	1
Development of Small Dupuytrens Cord at level of scar over MCP joint	1/32 (3.1%)	1
K-wire Migration	1/32 (3.1%)	1
Lucency around Bone anchor as evidenced on X-ray	1/32 (3.1%)	1
Mild Subluxation of Metacarpophalangeal (MCP) Joint	1/32 (3.1%)	1
Moisture with mild Erythema to surgical wound	1/32 (3.1%)	1
Neuropaxia around scar	1/32 (3.1%)	1
Pain and numbness to right thumb and radial three digits	1/32 (3.1%)	1
Superficial infection around wire site.	1/32 (3.1%)	1

Limitations/Caveats

Due to the nature of the study design, retrospective data was collected to the extent it was available.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.