Trial Outcomes & Findings for A Prospective Study Comparing Suture Anchor and Soft Tissue Pectoralis Major Tendon Techniques for Biceps Tenodesis (NCT NCT03529162)
NCT ID: NCT03529162
Last Updated: 2021-04-29
Results Overview
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
TERMINATED
NA
4 participants
This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.
2021-04-29
Participant Flow
Participant milestones
| Measure |
Pectoralis Major Technique (PMT)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Pectoralis Major Technique (PMT)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Baseline data was not collected on one subject for this measure and the patient was lost to follow up for subsequent scoring.
Baseline characteristics by cohort
| Measure |
Suture Anchor Technique (SA)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Pectoralis Major Technique (PMT)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=2 Participants
|
43 years
n=2 Participants
|
47 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
The American Shoulder and Elbow Surgeons Shoulder Score (ASES)
|
23.3 scores on a scale
n=2 Participants
|
25.0 scores on a scale
n=2 Participants
|
25 scores on a scale
n=4 Participants
|
|
The Disabilities of the Arm, Shoulder and Hand Score (DASH)
|
49.5 scores on a scale
n=2 Participants
|
62 scores on a scale
n=2 Participants
|
49.5 scores on a scale
n=4 Participants
|
|
Visual Analog Scale (VAS)
|
8.5 score on a scale
n=2 Participants
|
9 score on a scale
n=2 Participants
|
9 score on a scale
n=4 Participants
|
|
Single Assessment Numeric Evaluation (SANE)
|
35 score on a scale
n=2 Participants
|
12.5 score on a scale
n=2 Participants
|
27.5 score on a scale
n=4 Participants
|
|
Long Head of the Biceps Tendon Score (LHB)
|
80 scores on a scale
n=1 Participants • Baseline data was not collected on one subject for this measure and the patient was lost to follow up for subsequent scoring.
|
38 scores on a scale
n=2 Participants • Baseline data was not collected on one subject for this measure and the patient was lost to follow up for subsequent scoring.
|
42 scores on a scale
n=3 Participants • Baseline data was not collected on one subject for this measure and the patient was lost to follow up for subsequent scoring.
|
PRIMARY outcome
Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.Population: Sample size too small. Baseline data was collected on three of the four subjects and due to COVID-19 and the PI leaving research institution, additional long-term data not collected on remaining subjects.
The LHB score is a composite endpoint (maximum 100 points) that evaluates 'biceps pain and muscle cramps', 'cosmesis', and 'flexion strength at the elbow'. It is an outcome score specific for biceps tendon pathology. The score range is 0-100, with a higher score representing better function. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Outcome measures
| Measure |
Pectoralis Major Technique (PMT)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
n=1 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Change in Long Head of the Biceps Tendon Score (LHB)
3 Month Data
|
57.5 units on a scale
Interval 30.0 to 85.0
|
89 units on a scale
Interval 89.0 to 89.0
|
|
Change in Long Head of the Biceps Tendon Score (LHB)
6 Month Data
|
—
|
94 units on a scale
Interval 94.0 to 94.0
|
SECONDARY outcome
Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.Population: Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames.
The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. "0" is no pain and "10" is the worst pain. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Outcome measures
| Measure |
Pectoralis Major Technique (PMT)
n=1 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Change in Visual Analogue Scale (VAS)
3 Month Data
|
3 score on a scale
Interval 3.0 to 3.0
|
5.50 score on a scale
Interval 2.0 to 9.0
|
|
Change in Visual Analogue Scale (VAS)
6 Month Data
|
2 score on a scale
Interval 2.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.Population: Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames.
The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Outcome measures
| Measure |
Pectoralis Major Technique (PMT)
n=1 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)
3 Month Data
|
28 score on a scale
Interval 28.0 to 28.0
|
51 score on a scale
Interval 6.0 to 96.0
|
|
Change in Disabilities of the Arm, Shoulder, and Hand Score (DASH)
6 Month Data
|
10 score on a scale
Interval 10.0 to 10.0
|
—
|
SECONDARY outcome
Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.Population: Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames.
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure (PROM). Scoring is 1 to 100, with 100 being the highest function/no pain score. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Outcome measures
| Measure |
Pectoralis Major Technique (PMT)
n=1 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Change in Single Assessment Numeric Evaluation (SANE)
3 Month Data
|
50 units on a scale
Interval 50.0 to 50.0
|
52.5 units on a scale
Interval 7.0 to 98.0
|
|
Change in Single Assessment Numeric Evaluation (SANE)
6 Month Data
|
70 units on a scale
Interval 70.0 to 70.0
|
—
|
SECONDARY outcome
Timeframe: This score obtained pre-operatively, and post-operatively at 3 months, 6 months, which are reported.Population: Sample size too small. Baseline data was collected on all four subjects, but due to COVID-19 and the PI leaving research institution, additional long-term data not collected on all subjects. One subject was lost to follow up for outcome measure time frames.
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology regardless of their specific diagnosis. The ASES score contains a physician-rated and patient-rated section; however, only the pain visual analog scale (VAS) and 10 functional questions are typically used to tabulate the reported ASES score. The total score - 100 maximum points - is weighted 50% for pain and 50% for function. A score of 100 represents a better outcome and a score of 0 represents a worse outcome. The values represent the scores at 3 and 6 months, not a change of values from Baseline to 3 and 6 months.
Outcome measures
| Measure |
Pectoralis Major Technique (PMT)
n=1 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached by suturing the biceps tendon into the pectoralis major tendon.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
Suture Anchor Technique (SA)
n=2 Participants
If randomized to this group, the patient will receive an open subpectoral long head of biceps tenodesis technique whereby the long head of biceps is re-attached to the humerus using an FDA-approved suture anchor (SA) device for the suture anchor technique. The device to be used will be the Mitek Super Quick Anchor.
Long head of Biceps Tenodesis: Patients will be randomized into two different groups to compare biceps tenodesis techniques
|
|---|---|---|
|
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score
3 Month Data
|
65 score on a scale
Interval 65.0 to 65.0
|
49.2 score on a scale
Interval 16.7 to 81.7
|
|
Change in American Shoulder and Elbow Surgeons (ASES) Shoulder Score
6 Month Data
|
78.3 score on a scale
Interval 78.3 to 78.3
|
—
|
Adverse Events
Suture Anchor Technique (SA)
Pectoralis Major Technique (PMT)
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