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

Primary Purpose

Rotator Cuff Tears

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
suture anchor socket creation with punch
suture anchor socket creation with drill
Sponsored by
Matt Smith
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bone socket formation with a punch

Bone socket formation with a drill

Arm Description

suture anchor socket creation with punch

suture anchor socket creation with drill

Outcomes

Primary Outcome Measures

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
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.
VAS
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2020
Last Updated
March 15, 2023
Sponsor
Matt Smith
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1. Study Identification

Unique Protocol Identification Number
NCT04288570
Brief Title
Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
Acronym
Punch/Drill
Official Title
Punch vs. Drill Tunnel Use for Anchor Tunnel Creation and Correlation With Post-operative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matt Smith

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bone socket formation with a punch
Arm Type
Active Comparator
Arm Description
suture anchor socket creation with punch
Arm Title
Bone socket formation with a drill
Arm Type
Active Comparator
Arm Description
suture anchor socket creation with drill
Intervention Type
Procedure
Intervention Name(s)
suture anchor socket creation with punch
Intervention Description
suture anchor socket creation with punch
Intervention Type
Procedure
Intervention Name(s)
suture anchor socket creation with drill
Intervention Description
suture anchor socket creation with drill
Primary Outcome Measure Information:
Title
PROMIS Short Form - Physical Function
Description
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
Time Frame
2 weeks to 6 months
Title
SANE
Description
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.
Time Frame
2 weeks to 6 months
Title
VAS
Description
Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain
Time Frame
Post-op to 6 months
Title
PROMIS Short Form - Pain Interference
Description
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.
Time Frame
2 weeks to 6 months
Secondary Outcome Measure Information:
Title
MRI of the shoulder
Description
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
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Smith
Organizational Affiliation
University of Missouri Health System, Department of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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

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