Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

Study Overview
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Brief Summary
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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.

Official Title
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Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Procedure: suture anchor socket creation with punch
* Procedure: suture anchor socket creation with drill


Participation Criteria
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Eligibility Criteria
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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: Glenohumeral arthrosis Previous shoulder surgery Psychiatric diseasesMRI Rheumatologic diseases Fibromyalgia Spine diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bone socket formation with a punch<br>suture anchor socket creation with punch | Procedure: suture anchor socket creation with punch<br>* suture anchor socket creation with punch<br>|
| Active Comparator: Bone socket formation with a drill<br>suture anchor socket creation with drill | Procedure: suture anchor socket creation with drill<br>* suture anchor socket creation with drill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Short Form - Physical Function | PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. A single Physical Function capability score is obtained from a short form.Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Answers are rated | 2 weeks to 6 months | 
| 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. | 2 weeks to 6 months | 
| VAS | Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain | Post-op to 6 months | 
| PROMIS Short Form - Pain Interference | The PROMIS(r) Pain Interference instruments (adult and child) measure the self-reported consequences of pain on relevant aspects of a person's life. Each question usually has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. Answers are rated 1-5, 1 being no pain and 5 being very severe. | 2 weeks to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 edema pattern in the proximal humerus | 2 weeks |