Trial Outcomes & Findings for Early Mobilization Following Mini-Open Rotator Cuff Repair (NCT NCT01741272)
NCT ID: NCT01741272
Last Updated: 2021-10-28
Results Overview
Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level). Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
189 participants
Primary outcome timeframe
Baseline, 6 weeks, 3, 6, 12, 24 months
Results posted on
2021-10-28
Participant Flow
Participant milestones
| Measure |
Group A (Usual Care)
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
97
|
|
Overall Study
COMPLETED
|
92
|
97
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Mobilization Following Mini-Open Rotator Cuff Repair
Baseline characteristics by cohort
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
n=113 Participants
|
55.4 years
n=163 Participants
|
55.1 years
n=160 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=113 Participants
|
40 Participants
n=163 Participants
|
74 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=113 Participants
|
57 Participants
n=163 Participants
|
115 Participants
n=160 Participants
|
|
Region of Enrollment
Canada
|
92 participants
n=113 Participants
|
97 participants
n=163 Participants
|
189 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 3, 6, 12, 24 monthsTwo-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level). Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.
Outcome measures
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks Forward Flexion
|
73.2 degrees
Standard Deviation 32.1
|
84.1 degrees
Standard Deviation 30.2
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 months Forward Flexion
|
149.6 degrees
Standard Deviation 17.8
|
149.9 degrees
Standard Deviation 12.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks Abduction
|
68.5 degrees
Standard Deviation 27.8
|
81.4 degrees
Standard Deviation 26.3
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months Abduction
|
113.0 degrees
Standard Deviation 26.2
|
112.1 degrees
Standard Deviation 29.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months Abduction
|
139.1 degrees
Standard Deviation 25.8
|
134.6 degrees
Standard Deviation 27.3
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months Abduction
|
149.9 degrees
Standard Deviation 23.2
|
144.7 degrees
Standard Deviation 22.6
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 months Abduction
|
155.5 degrees
Standard Deviation 20.2
|
150.7 degrees
Standard Deviation 20.0
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline External Rotation in Abduction
|
65.2 degrees
Standard Deviation 35.6
|
56.9 degrees
Standard Deviation 36.2
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks External Rotation in Abduction
|
15.0 degrees
Standard Deviation 28.2
|
22.6 degrees
Standard Deviation 29.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months External Rotation in Abduction
|
53.7 degrees
Standard Deviation 26.9
|
52.6 degrees
Standard Deviation 29.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline Internal Rotation in Abduction
|
30.7 degrees
Standard Deviation 19.9
|
26.7 degrees
Standard Deviation 19.2
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline Horizontal Adduction
|
16.9 degrees
Standard Deviation 14.2
|
14.4 degrees
Standard Deviation 11.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline Forward Flexion
|
124.4 degrees
Standard Deviation 33.9
|
120.2 degrees
Standard Deviation 30.2
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months Forward Flexion
|
118.5 degrees
Standard Deviation 25.5
|
120.0 degrees
Standard Deviation 25.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months Forward Flexion
|
135.9 degrees
Standard Deviation 21.6
|
136.3 degrees
Standard Deviation 18.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months Forward Flexion
|
144.8 degrees
Standard Deviation 19.2
|
144.8 degrees
Standard Deviation 12.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline Abduction
|
117.4 degrees
Standard Deviation 40.1
|
116.3 degrees
Standard Deviation 40.3
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months External Rotation in Abduction
|
74.2 degrees
Standard Deviation 17.1
|
73.1 degrees
Standard Deviation 17.3
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months External Rotation in Abduction
|
80.3 degrees
Standard Deviation 13.9
|
77.9 degrees
Standard Deviation 13.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 monthsExternal Rotation in Abduction
|
84.0 degrees
Standard Deviation 11.9
|
81.5 degrees
Standard Deviation 11.7
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks Internal Rotation in Abduction
|
7.7 degrees
Standard Deviation 14.4
|
11.9 degrees
Standard Deviation 16.1
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months Internal Rotation in Abduction
|
24.1 degrees
Standard Deviation 13.8
|
23.7 degrees
Standard Deviation 16.0
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months Internal Rotation in Abduction
|
32.9 degrees
Standard Deviation 12.0
|
32.2 degrees
Standard Deviation 12.7
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months Internal Rotation in Abduction
|
34.8 degrees
Standard Deviation 10.3
|
33.9 degrees
Standard Deviation 9.9
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 months Internal Rotation in Abduction
|
35.7 degrees
Standard Deviation 10.2
|
34.9 degrees
Standard Deviation 9.7
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks Horizontal Adduction
|
5.9 degrees
Standard Deviation 9.1
|
6.4 degrees
Standard Deviation 7.5
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months Horizontal Adduction
|
14.2 degrees
Standard Deviation 9.7
|
12.5 degrees
Standard Deviation 10.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months Horizontal Adduction
|
17.6 degrees
Standard Deviation 9.0
|
16.2 degrees
Standard Deviation 8.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months Horizontal Adduction
|
17.1 degrees
Standard Deviation 8.0
|
17.5 degrees
Standard Deviation 7.9
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 months Horizontal Adduction
|
15.1 degrees
Standard Deviation 6.0
|
15.2 degrees
Standard Deviation 6.9
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
Baseline Scaption
|
123.8 degrees
Standard Deviation 36.1
|
125.1 degrees
Standard Deviation 31.5
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 weeks Scaption
|
72.1 degrees
Standard Deviation 31.8
|
86.1 degrees
Standard Deviation 30.7
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
3 months Scaption
|
121.6 degrees
Standard Deviation 26.9
|
122.2 degrees
Standard Deviation 24.4
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
6 months Scaption
|
140.3 degrees
Standard Deviation 22.1
|
139.6 degrees
Standard Deviation 20.2
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
12 months Scaption
|
149.1 degrees
Standard Deviation 18.4
|
146.6 degrees
Standard Deviation 17.0
|
|
Change in Range of Motion (ROM)From Baseline to 24 Months
24 months Scaption
|
151.0 degrees
Standard Deviation 17.7
|
150.4 degrees
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 monthsShoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.
Outcome measures
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Pain Questionnaire
Baseline Pain at rest
|
4.0 centimeters
Standard Deviation 2.8
|
4.0 centimeters
Standard Deviation 2.8
|
|
Pain Questionnaire
6 weeks Pain at rest
|
2.3 centimeters
Standard Deviation 2.0
|
2.4 centimeters
Standard Deviation 2.5
|
|
Pain Questionnaire
3 months Pain at rest
|
1.3 centimeters
Standard Deviation 1.6
|
1.4 centimeters
Standard Deviation 1.6
|
|
Pain Questionnaire
6 months Pain at rest
|
0.93 centimeters
Standard Deviation 1.6
|
0.78 centimeters
Standard Deviation 1.3
|
|
Pain Questionnaire
12 months Pain at rest
|
0.85 centimeters
Standard Deviation 1.7
|
0.49 centimeters
Standard Deviation 0.81
|
|
Pain Questionnaire
24 months Pain at rest
|
0.53 centimeters
Standard Deviation 1.3
|
0.41 centimeters
Standard Deviation 0.89
|
|
Pain Questionnaire
Baseline Pain with activity
|
5.2 centimeters
Standard Deviation 2.8
|
5.5 centimeters
Standard Deviation 3.1
|
|
Pain Questionnaire
6 weeks Pain with activity
|
4.0 centimeters
Standard Deviation 2.3
|
3.3 centimeters
Standard Deviation 2.1
|
|
Pain Questionnaire
3 months Pain with activity
|
2.8 centimeters
Standard Deviation 2.4
|
2.4 centimeters
Standard Deviation 2.0
|
|
Pain Questionnaire
6 months Pain with activity
|
1.8 centimeters
Standard Deviation 2.2
|
1.6 centimeters
Standard Deviation 2.0
|
|
Pain Questionnaire
12 months Pain with activity
|
1.1 centimeters
Standard Deviation 1.9
|
1.1 centimeters
Standard Deviation 1.4
|
|
Pain Questionnaire
24 months Pain with activity
|
0.74 centimeters
Standard Deviation 1.4
|
0.81 centimeters
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24 monthsHealth related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.
Outcome measures
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
WORC Questionnaire
Baseline WORC Score
|
40.1 units on a scale
Interval 4.5 to 87.0
|
40.1 units on a scale
Interval 2.4 to 86.6
|
|
WORC Questionnaire
24 months WORC Score
|
90.9 units on a scale
Interval 15.7 to 100.0
|
89.4 units on a scale
Interval 48.4 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, 24 monthsThe Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.
Outcome measures
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Abduction Strength Using the Power Component of the Constant Score
Mean Constant Power - Baseline
|
8.7 units on a scale
Interval 0.0 to 25.0
|
8.3 units on a scale
Interval 0.0 to 25.0
|
|
Abduction Strength Using the Power Component of the Constant Score
Mean Constant Power - 24 months
|
16.5 units on a scale
Interval 0.0 to 25.0
|
16.3 units on a scale
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: 2 & 6 weeks, 3, 6, 12, 24 monthsPopulation: 37 subjects (17 Early Mobilization, 20 Standard Rehabilitation) had non-re-tear complications. 5 subjects reported more than one complication.
Incidence of any surgical or medical complications will be prospectively documented.
Outcome measures
| Measure |
Group A (Usual Care)
n=92 Participants
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 Participants
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Complications
|
20 participants
|
17 participants
|
Adverse Events
Group A (Usual Care)
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Group B (Early ROM)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A (Usual Care)
n=92 participants at risk
Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling
Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
|
Group B (Early ROM)
n=97 participants at risk
Will use the sling for comfort only. Intervention: Procedure: No sling
No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Non re-tear complications
|
21.7%
20/92
|
17.5%
17/97
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place