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: Completed
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Procedure: suture anchor socket creation with punch; Procedure: suture anchor socket creation with drill

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

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

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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Matt Smith
• Investigators: Principal Investigator: Matthew J Smith, University of Missouri Health System, Department of Orthopaedic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): July 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): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

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