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To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone socket formation with a punch | Active Comparator | suture anchor socket creation with punch |
|
| Bone socket formation with a drill | Active Comparator | suture anchor socket creation with drill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suture anchor socket creation with punch | Procedure | suture anchor socket creation with punch |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
| 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. | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
| Visual Analogue Scale | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
| 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). | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Smith | University of Missouri Health System, Department of Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bone Socket Formation With a Punch | suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch |
| FG001 | Bone Socket Formation With a Drill | suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bone Socket Formation With a Punch | suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch |
| BG001 | Bone Socket Formation With a Drill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | T-Score | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bone Socket Formation With a Punch | suture anchor socket creation with punch suture anchor socket creation with punch: suture anchor socket creation with punch |
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A limitation of our study was that the surgeon was not blinded to the intervention given that surgical technique was the variable in question for the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicki L Jones | UMissouri | 573-882-7583 | jonesvicki@health.missouri.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 24, 2020 | Nov 29, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| suture anchor socket creation with drill | Procedure | suture anchor socket creation with drill |
|
suture anchor socket creation with drill
suture anchor socket creation with drill: suture anchor socket creation with drill
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
|
|
|
| Primary | Visual Analogue Scale | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | Posted | Mean | Standard Deviation | score on a scale | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | T-Score | Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months |
|
|
|
| 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) | The analysis population include all participants that completed the MRI at the 2 week post-op evaluation. | Posted | Mean | Full Range | mm^2 | 2 weeks |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Bone Socket Formation With a Drill | suture anchor socket creation with drill suture anchor socket creation with drill: suture anchor socket creation with drill | 0 | 22 | 0 | 22 | 0 | 22 |
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| 6 Weeks |
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| 3 Months |
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| 6 Months |
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| 6 Weeks |
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| 3 Months |
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| 6 Months |
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| 6 Weeks |
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| 3 Months |
|
| 6 Months |
|