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

NCT04288570 | Completed Results

• 1 other identifier: 2019842
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Magnetic Resonance Imaging (MRI) of the Shoulder

  2 weeks

Study Arms (2)

Bone socket formation with a punch

ACTIVE COMPARATOR

suture anchor socket creation with punch

Procedure: suture anchor socket creation with punch

Bone socket formation with a drill

ACTIVE COMPARATOR

suture anchor socket creation with drill

Procedure: suture anchor socket creation with drill

Interventions

suture anchor socket creation with punch PROCEDURE

suture anchor socket creation with punch

Bone socket formation with a punch

suture anchor socket creation with drill PROCEDURE

suture anchor socket creation with drill

Bone socket formation with a drill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Glenohumeral arthrosis
• Previous shoulder surgery
• Psychiatric diseasesMRI
• Rheumatologic diseases
• Fibromyalgia
• Spine diseases

Sponsors & Collaborators

• Matt Smith: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Limitations and Caveats

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

Results Point of Contact

• Title: Vicki L Jones
• Organization: UMissouri

jonesvicki@health.missouri.edu

573-882-7583

Study Officials

• Matthew J Smith

  University of Missouri Health System, Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR OF CLINICAL, MOI OUTPATIENT MEDICAL DIRECTOR, Orthopaedic Surgery

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 28, 2020
• Study Start: April 1, 2020
• Primary Completion: June 15, 2023
• Study Completion: July 1, 2023
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Locations

US (1)