Achilles Tendon Repairs/Reconstructions, Biceps Tendon Reattachment, Hallux Valgus Repairs, Lateral Epicondylitis Repair, Medial or Lateral Instability Repairs/Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Midfoot Reconstructions, Scapholunate Ligament Reconstructions, Ulnar or Radial Collateral Ligament Reconstructions
Conditions
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.
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.
Interventions
DEVICEMINITAC 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.
Sponsors
Smith & Nephew, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Minitac Ti 2.0 Suture Anchor |
|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 14.06 |
| Body Mass Index | 28.11 kg/m^2 STANDARD_DEVIATION 6.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Height | 172.19 cm STANDARD_DEVIATION 10.52 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Other | 32 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Region of Enrollment Australia | 32 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 17 Participants |
| Weight | 83.93 kg STANDARD_DEVIATION 24.14 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 8 / 32 |
| serious Total, serious adverse events | 1 / 32 |
Outcome results
Primary
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.
Time frame: 6 months
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minitac Ti 2.0 Suture Anchor | Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative | 31 Participants |
Secondary
Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
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
Population: 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 | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minitac Ti 2.0 Suture Anchor | Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative | 4 Participants |
Other Pre-specified
Range of Motion (ROM)
Range of motion defined as having full functional arc at 6 month and 12 month post-operative visits
Time frame: 6 and 12 months
Population: 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 | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minitac Ti 2.0 Suture Anchor | Range of Motion (ROM) | 6 months - has full functional arc | Yes | 6 Participants |
| Minitac Ti 2.0 Suture Anchor | Range of Motion (ROM) | 6 months - has full functional arc | No | 25 Participants |
| Minitac Ti 2.0 Suture Anchor | Range of Motion (ROM) | 12 months - has full functional arc | Yes | 1 Participants |
| Minitac Ti 2.0 Suture Anchor | Range of Motion (ROM) | 12 months - has full functional arc | No | 3 Participants |