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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04186481




Registration number
NCT04186481
Ethics application status
Date submitted
2/12/2019
Date registered
4/12/2019
Date last updated
20/05/2020

Titles & IDs
Public title
A Study of the Safety and Performance of the MINITAC? Titanium 2.0 Suture Anchor
Scientific title
Safety and Performance of MINITAC? Ti 2.0 Suture Anchor in Extremities
Secondary ID [1] 0 0
MINI.PMCF.2018.11
Universal Trial Number (UTN)
Trial acronym
MINITAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hallux Valgus Repairs 0 0
Medial or Lateral Instability Repairs/Reconstructions 0 0
Achilles Tendon Repairs/Reconstructions 0 0
Midfoot Reconstructions 0 0
Metatarsal Ligament/Tendon Repairs/Reconstructions 0 0
Scapholunate Ligament Reconstructions 0 0
Ulnar or Radial Collateral Ligament Reconstructions 0 0
Lateral Epicondylitis Repair 0 0
Biceps Tendon Reattachment 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - MINITAC Ti 2.0 suture anchor

Minitac Ti 2.0 suture anchor - Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical success rate (%) of the MINITAC? Ti 2.0 Suture Anchor in extremities at 6 months post-operative - Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Clinical success rate (%) of the MINITAC? Ti 2.0 Suture Anchor in extremities at 12 months post-operative
Timepoint [1] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Maitland Hand and Othopaedic surgery - Ashtonfield
Recruitment postcode(s) [1] 0 0
2323 - Ashtonfield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Smith & Nephew, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04186481
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc)
Address 0 0
Maitland Hand and Othopaedic surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications