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

NCT ID: NCT04288570

Last Updated: 2025-04-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-07-01

Brief Summary

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

Detailed Description

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Conditions

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Rotator Cuff Tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone socket formation with a punch

suture anchor socket creation with punch

Group Type ACTIVE_COMPARATOR

suture anchor socket creation with punch

Intervention Type PROCEDURE

suture anchor socket creation with punch

Bone socket formation with a drill

suture anchor socket creation with drill

Group Type ACTIVE_COMPARATOR

suture anchor socket creation with drill

Intervention Type PROCEDURE

suture anchor socket creation with drill

Interventions

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suture anchor socket creation with punch

suture anchor socket creation with punch

Intervention Type PROCEDURE

suture anchor socket creation with drill

suture anchor socket creation with drill

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matt Smith

OTHER

Sponsor Role lead

Responsible Party

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Matt Smith

ASSOCIATE PROFESSOR OF CLINICAL, MOI OUTPATIENT MEDICAL DIRECTOR, Orthopaedic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Matthew J Smith

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Health System, Department of Orthopaedic Surgery

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2019842

Identifier Type: -

Identifier Source: org_study_id

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