Skillful Neglect Vs Repair For Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair.

September 21, 2023 updated by: Mohamed Ashraf Abdallah

Skillful Neglect Vs Repair For Upper Border Subscapularis Tear Associated With Posterosuperior Cuff Tears Repair In Non-Athletes: A Randomized Controlled Trial

The purpose of this study is to compare functional outcomes of Skillful Neglect & arthroscopic repair of upper border subscapularis tear in La fosse type 1 and type 2 with biceps tenotomy in non-athletes,30 shoulders subdivided randomly into 2 groups, 15 patients in group 1 (patient treated by skillful neglect with biceps tenotomy) and 15 patients in group 2 (patients treated by arthroscopic repair with biceps tenotomy)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

patients are randomized chosen then a shoulder arthroscope is done for all patients with biceps tenotomy but in group1 the investigators are neglecting the upper border tears and in group 2 the investigators are repairing upper border tears with anchors then after the procedure is completed the investigators will follow up by ASES score

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Yahia Mo Haroun
  • Phone Number: 00201006124615

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain Shams University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with combined upper subscapularis border tear in Lafosse type 1 and type 2.

Exclusion Criteria:

  • Glenohumeral arthritis.
  • Patients with other intra-articular pathology like SLAP lesions.
  • Neural damage (Brachial plexus injury).
  • Revision cases.
  • Patient with subscapularis border tear type 3, type 4, and type 5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: group 1 (patient treated by skillful neglect with biceps tenotomy)
neglect of upper border subscapularis tear and doing biceps tenotomy
Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.

  • Semisetting position under GA.
  • Standard shoulder arthroscopy with standard portals for RC repair.
  • Inspection of articular surface of rotator cuff and biceps tendon.
  • Bursectomy, visualization of all rotators.
  • Mobilization is done for associated rotator tears by shaver and radiofrequency device.
  • Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
  • Skillful neglect to the tear.
  • Rotator repair technique by RC anchors
  • Biceps Tenotomy will be done in all cases by cutting of LHBT.
Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.

  • Semisetting position under GA.
  • Standard shoulder arthroscopy with standard portals for RC repair.
  • Inspection of articular surface of rotator cuff and biceps tendon.
  • Bursectomy, visualization of all rotators.
  • Mobilization is done for associated rotator tears by shaver and radiofrequency device.
  • Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
  • Skillful neglect to the tear.
  • Rotator repair technique by RC anchors
  • Biceps Tenotomy will be done in all cases by cutting of LHBT.
Active Comparator: group 2 (patient treated by arthroscopic repair with biceps tenotomy)
repair of upper border subscapularis tear and doing biceps tenotomy
Procedure: skillful neglect Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear conservative treatment which is considered the standard technique.

  • Semisetting position under GA.
  • Standard shoulder arthroscopy with standard portals for RC repair.
  • Inspection of articular surface of rotator cuff and biceps tendon.
  • Bursectomy, visualization of all rotators.
  • Mobilization is done for associated rotator tears by shaver and radiofrequency device.
  • Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
  • Skillful neglect to the tear.
  • Rotator repair technique by RC anchors
  • Biceps Tenotomy will be done in all cases by cutting of LHBT.
Procedure: arthroscopic repair Of upper subscapularis tear in Lafosse type 1 and type 2 with long head biceps tenotomy .

The following technique will be utilized for confirm isolated or combined upper subscapularis border partial tear repair which is considered the standard technique.

  • Semisetting position under GA.
  • Standard shoulder arthroscopy with standard portals for RC repair.
  • Inspection of articular surface of rotator cuff and biceps tendon.
  • Bursectomy, visualization of all rotators.
  • Mobilization is done for associated rotator tears by shaver and radiofrequency device.
  • Both preoperative Statistics randomization that is used to determine which case will be repaired and intraoperative loss of tension of the elongated aspect of the tendon are used to confirm diagnosis and treatment of upper subscapularis border tear.
  • Skillful neglect to the tear.
  • Rotator repair technique by RC anchors
  • Biceps Tenotomy will be done in all cases by cutting of LHBT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
american shoulder elbow score
Time Frame: after 6months and 12 months
scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points.
after 6months and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analogue score
Time Frame: Post operative 6months and 12 months
subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Post operative 6months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mohamed Ashraf Abdallah

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: mohamed as abdallah, master, Ain shams university
  • Study Chair: Amr Mo Abdelhady, Ain shams university
  • Study Director: Maged Mo Samy, Ain shams university
  • Study Director: Mohamed Ha Sobhy, Ain shams university
  • Study Director: Yahia Mo Haroun, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MD 218/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings