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Completed

NCT Number: NCT04288570

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

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

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Key information

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

suture anchor socket creation with punch

Procedure

suture anchor socket creation with punch

suture anchor socket creation with drill

Procedure

suture anchor socket creation with drill

Primary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function Short Form

    Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

    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).

  2. Single Assessment Numeric Evaluation (SANE)

    Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

    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.

  3. Visual Analogue Scale

    Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

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

  4. PROMIS - Pain Interference

    Time frame: Preop, 2 Weeks, 6 Weeks, 3 Months, 6 Months

    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).

Secondary outcomes

  1. Magnetic Resonance Imaging (MRI) of the Shoulder

    Time frame: 2 weeks

    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)

Sponsors and collaborators

Lead sponsor

Matt Smith

Other

Registry information

Acronym: Punch/Drill

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2020
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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