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

Rotator Cuff Tears Clinical Trial

— Punch/Drill  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04288570
• Other study ID #: 2019842
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• suture anchor socket creation with punch
suture anchor socket creation with punch
• suture anchor socket creation with drill
suture anchor socket creation with drill

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Matt Smith

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	VAS	Patient Reported Outcome Measure - pain Scale: 0-10. 0 being no pain and 10 being unbearable pain	Post-op to 6 months
Primary	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	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