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

To determine if different techniques used in the creation of suture anchor socket creation can influence post-op pain following rotator cuff repair.

Study Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: suture anchor socket creation with punch; Procedure: suture anchor socket creation with drill

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzin M Cunningham, BS; Phone Number: 573-884-4565; Email: suzincunningham@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bone socket formation with a punch; suture anchor socket creation with punch	Procedure: suture anchor socket creation with punch; suture anchor socket creation with punch
Active Comparator: Bone socket formation with a drill; suture anchor socket creation with drill	Procedure: suture anchor socket creation with drill; suture anchor socket creation with drill

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Matt Smith

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Pain, Postoperative; Rotator Cuff Injuries
• Other Study ID Numbers: 2019842

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No