Trial Outcomes & Findings for Evaluation of the Healicoil Suture Anchor for Rotator Cuff Repair (NCT NCT02759458)
NCT ID: NCT02759458
Last Updated: 2023-03-14
Results Overview
This is a survey that assess the subject's current functionality and ability to complete daily tasks. The ASES score can be viewed as a single 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. The higher the number on the scale, the better the pain level and subject's current functionality and ability to complete daily tasks; 100 means no shoulder pain and perfect functionality and ability to complete daily tasks.
COMPLETED
NA
40 participants
12-month
2023-03-14
Participant Flow
Participant milestones
| Measure |
Healicoil
Patients that met the inclusion criteria who were randomly selected to receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Healicoil Anchor
|
Twinfix
Patients that met the inclusion criteria who were randomly selected to not receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Twinfix Anchor
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healicoil
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Healicoil Anchor
|
Twinfix
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to not receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Twinfix Anchor
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
45 years
n=20 Participants
|
47 years
n=20 Participants
|
46 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
20 participants
n=20 Participants
|
40 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 12-monthThis is a survey that assess the subject's current functionality and ability to complete daily tasks. The ASES score can be viewed as a single 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. The higher the number on the scale, the better the pain level and subject's current functionality and ability to complete daily tasks; 100 means no shoulder pain and perfect functionality and ability to complete daily tasks.
Outcome measures
| Measure |
Healicoil
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Healicoil Anchor
|
Twinfix
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to not receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Twinfix Anchor
|
|---|---|---|
|
American Shoulder and Elbow Surgeons( ASES)-Shoulder Form
|
30 score on a scale
Interval 25.0 to 35.0
|
30 score on a scale
Interval 25.0 to 35.0
|
PRIMARY outcome
Timeframe: 12-monthThis is a single question survey that asks how the patient's shoulder is feeling. The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. The higher the number on the scale, the better the patient's shoulder is feeling compared to their pre-injury baseline. 100 means the patient's shoulder feels in perfect health compared with pre-injury baseline.
Outcome measures
| Measure |
Healicoil
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Healicoil Anchor
|
Twinfix
n=20 Participants
Patients that met the inclusion criteria who were randomly selected to not receive the Healicoil anchor for their rotator cuff repair.
Smith \& Nephew Twinfix Anchor
|
|---|---|---|
|
Single Assessment Numeric Evaluation (SANE) Form
|
50 score on a scale
Interval 45.0 to 55.0
|
48 score on a scale
Interval 45.0 to 55.0
|
Adverse Events
Healicoil
Twinfix
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place