Rotator Cuff Tears
Conditions
Brief summary
To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.
Interventions
PROCEDUREsuture anchor socket creation with punch
suture anchor socket creation with punch
PROCEDUREsuture anchor socket creation with drill
suture anchor socket creation with drill
Sponsors
Matt Smith
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
a. Patient's aged 18-80 years old with diagnosis of rotator cuff tear having failed non-operative management and being indicated for surgical intervention with use of suture anchors.
Exclusion criteria
1. Glenohumeral arthrosis 2. Previous shoulder surgery 3. Psychiatric diseasesMRI 4. Rheumatologic diseases 5. Fibromyalgia 6. Spine diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months | The PROMIS Physical Function Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate better physical function. Responses use a Likert scale: 1 = Unable to do, 2 = With much difficulty, 3 = With some difficulty, 4 = With a little difficulty, 5 = Without any difficulty. Raw scores are summed and converted to T-scores. 50 = average function, 60 = 1 SD above (better), 40 = 1 SD below (worse). |
| Single Assessment Numeric Evaluation (SANE) | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months | The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100% with 100% being normal. |
| Visual Analogue Scale | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain |
| PROMIS - Pain Interference | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months | The PROMIS Pain Interference Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate greater pain interference. Responses use a Likert scale: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much. Raw scores are summed and converted to T-scores. 50 = average pain interference, 60 = 1 SD above (worse), 40 = 1 SD below (better). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnetic Resonance Imaging (MRI) of the Shoulder | 2 weeks | MRI of the shoulder of the first 5 patients in each group will be obtained at 2 weeks post-op for evaluation of bone marrow lesion in the proximal humerus. Bone marrow lesion size measured in mm2 on a calibrated MR image from 0 (no lesion, better) to 180 (large lesion, worse) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone Socket Formation With a Punch suture anchor socket creation with punch
suture anchor socket creation with punch: suture anchor socket creation with punch | 21 |
| Bone Socket Formation With a Drill suture anchor socket creation with drill
suture anchor socket creation with drill: suture anchor socket creation with drill | 22 |
| Total | 43 |
Baseline characteristics
| Characteristic | Bone Socket Formation With a Drill | Total | Bone Socket Formation With a Punch |
|---|---|---|---|
| Age, Continuous | 59.3 years | 60.3 years | 61.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 39 Participants | 21 Participants |
| Sex: Female, Male Female | 12 Participants | 19 Participants | 7 Participants |
| Sex: Female, Male Male | 10 Participants | 24 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
Primary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form
The PROMIS Physical Function Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate better physical function. Responses use a Likert scale: 1 = Unable to do, 2 = With much difficulty, 3 = With some difficulty, 4 = With a little difficulty, 5 = Without any difficulty. Raw scores are summed and converted to T-scores. 50 = average function, 60 = 1 SD above (better), 40 = 1 SD below (worse).
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Socket Formation With a Punch | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 2 Weeks | 36.81 T-Score | Standard Deviation 2.42 |
| Bone Socket Formation With a Punch | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 3 Months | 44.41 T-Score | Standard Deviation 2.23 |
| Bone Socket Formation With a Punch | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 6 Weeks | 42.74 T-Score | Standard Deviation 2.42 |
| Bone Socket Formation With a Punch | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 6 Months | 46.90 T-Score | Standard Deviation 2.52 |
| Bone Socket Formation With a Punch | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | Preop | 41.51 T-Score | Standard Deviation 2.22 |
| Bone Socket Formation With a Drill | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 6 Months | 46.31 T-Score | Standard Deviation 2.31 |
| Bone Socket Formation With a Drill | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | Preop | 40.54 T-Score | Standard Deviation 2.24 |
| Bone Socket Formation With a Drill | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 2 Weeks | 32.16 T-Score | Standard Deviation 2.58 |
| Bone Socket Formation With a Drill | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 6 Weeks | 37.90 T-Score | Standard Deviation 2.52 |
| Bone Socket Formation With a Drill | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form | 3 Months | 42.22 T-Score | Standard Deviation 2.24 |
Primary
PROMIS - Pain Interference
The PROMIS Pain Interference Short Form uses T-scores (Mean = 50, SD = 10), where higher scores indicate greater pain interference. Responses use a Likert scale: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, 5 = Very much. Raw scores are summed and converted to T-scores. 50 = average pain interference, 60 = 1 SD above (worse), 40 = 1 SD below (better).
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Socket Formation With a Punch | PROMIS - Pain Interference | 3 Months | 55.51 T-Score | Standard Deviation 1.93 |
| Bone Socket Formation With a Punch | PROMIS - Pain Interference | 6 Months | 54.20 T-Score | Standard Deviation 3 |
| Bone Socket Formation With a Punch | PROMIS - Pain Interference | Preop | 62.23 T-Score | Standard Deviation 1.74 |
| Bone Socket Formation With a Punch | PROMIS - Pain Interference | 2 Weeks | 54.76 T-Score | Standard Deviation 1.95 |
| Bone Socket Formation With a Punch | PROMIS - Pain Interference | 6 Weeks | 55.02 T-Score | Standard Deviation 1.98 |
| Bone Socket Formation With a Drill | PROMIS - Pain Interference | 6 Weeks | 58.52 T-Score | Standard Deviation 2.58 |
| Bone Socket Formation With a Drill | PROMIS - Pain Interference | 2 Weeks | 61.66 T-Score | Standard Deviation 2.43 |
| Bone Socket Formation With a Drill | PROMIS - Pain Interference | 6 Months | 54.27 T-Score | Standard Deviation 2.55 |
| Bone Socket Formation With a Drill | PROMIS - Pain Interference | 3 Months | 56.83 T-Score | Standard Deviation 2.03 |
| Bone Socket Formation With a Drill | PROMIS - Pain Interference | Preop | 63.11 T-Score | Standard Deviation 1.84 |
Primary
Single Assessment Numeric Evaluation (SANE)
The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measure. A SANE score requires the patient to rate their knee function on a scale of 0 to 100% with 100% being normal.
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Socket Formation With a Punch | Single Assessment Numeric Evaluation (SANE) | 2 Weeks | 22.0 score on a scale | Standard Deviation 22.67 |
| Bone Socket Formation With a Punch | Single Assessment Numeric Evaluation (SANE) | 3 Months | 38.83 score on a scale | Standard Deviation 25.14 |
| Bone Socket Formation With a Punch | Single Assessment Numeric Evaluation (SANE) | 6 Weeks | 35 score on a scale | Standard Deviation 29.53 |
| Bone Socket Formation With a Punch | Single Assessment Numeric Evaluation (SANE) | 6 Months | 68.36 score on a scale | Standard Deviation 31.63 |
| Bone Socket Formation With a Punch | Single Assessment Numeric Evaluation (SANE) | PreOp | 35.86 score on a scale | Standard Deviation 17.22 |
| Bone Socket Formation With a Drill | Single Assessment Numeric Evaluation (SANE) | 6 Months | 76.23 score on a scale | Standard Deviation 20.67 |
| Bone Socket Formation With a Drill | Single Assessment Numeric Evaluation (SANE) | PreOp | 32.14 score on a scale | Standard Deviation 21.76 |
| Bone Socket Formation With a Drill | Single Assessment Numeric Evaluation (SANE) | 2 Weeks | 17.06 score on a scale | Standard Deviation 22.1 |
| Bone Socket Formation With a Drill | Single Assessment Numeric Evaluation (SANE) | 6 Weeks | 22.5 score on a scale | Standard Deviation 14.62 |
| Bone Socket Formation With a Drill | Single Assessment Numeric Evaluation (SANE) | 3 Months | 47.2 score on a scale | Standard Deviation 24.27 |
Primary
Visual Analogue Scale
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bone Socket Formation With a Punch | Visual Analogue Scale | 2 Weeks | 1.14 score on a scale | Standard Deviation 1.46 |
| Bone Socket Formation With a Punch | Visual Analogue Scale | 3 Months | 2.06 score on a scale | Standard Deviation 1.84 |
| Bone Socket Formation With a Punch | Visual Analogue Scale | 6 Weeks | 1.78 score on a scale | Standard Deviation 1.62 |
| Bone Socket Formation With a Punch | Visual Analogue Scale | 6 Months | 2.64 score on a scale | Standard Deviation 2.42 |
| Bone Socket Formation With a Punch | Visual Analogue Scale | Preop | 4.86 score on a scale | Standard Deviation 2.01 |
| Bone Socket Formation With a Drill | Visual Analogue Scale | 6 Months | 2.54 score on a scale | Standard Deviation 2.5 |
| Bone Socket Formation With a Drill | Visual Analogue Scale | Preop | 4.95 score on a scale | Standard Deviation 2.48 |
| Bone Socket Formation With a Drill | Visual Analogue Scale | 2 Weeks | 3.56 score on a scale | Standard Deviation 2.83 |
| Bone Socket Formation With a Drill | Visual Analogue Scale | 6 Weeks | 2.11 score on a scale | Standard Deviation 2.51 |
| Bone Socket Formation With a Drill | Visual Analogue Scale | 3 Months | 2.33 score on a scale | Standard Deviation 1.96 |
Secondary
Magnetic Resonance Imaging (MRI) of the Shoulder
MRI of the shoulder of the first 5 patients in each group will be obtained at 2 weeks post-op for evaluation of bone marrow lesion in the proximal humerus. Bone marrow lesion size measured in mm2 on a calibrated MR image from 0 (no lesion, better) to 180 (large lesion, worse)
Time frame: 2 weeks
Population: The analysis population include all participants that completed the MRI at the 2 week post-op evaluation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bone Socket Formation With a Punch | Magnetic Resonance Imaging (MRI) of the Shoulder | 20.4 mm^2 |
| Bone Socket Formation With a Drill | Magnetic Resonance Imaging (MRI) of the Shoulder | 21.7 mm^2 |