NCT06743061

Brief Summary

Chronic massive rotator cuff tears (MMRCTs) are a significant orthopedic challenge, often leading to significant shoulder pain and functional impairment. While surgical intervention is a common treatment approach, long-term outcomes and the optimal surgical technique remain debatable. Arthroscopic debridement, subacromial decompression, and biceps tenotomy are frequently employed procedures, but their long-term effectiveness in managing MMRCTs is not fully understood. A comprehensive understanding of the long-term outcomes of these procedures is crucial for guiding clinical decision-making and patient counseling. The study aims to evaluate the long-term clinical and functional outcomes of arthroscopic debridement, subacromial decompression, and biceps tenotomy in patients with chronic massive rotator cuff tears. By analyzing a cohort of patients who underwent these procedures, we will assess factors influencing long-term outcomes, such as patient demographics, preoperative functional status, and surgical technique. Furthermore, we will compare the long-term results of this surgical approach to other treatment modalities, including open repair and conservative management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2021

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 16, 2024

Last Update Submit

December 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients reported having at least a 50% obtaining the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.

    The Success rate of Arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator cuff tear in making the patients able to obtain the normal angle of forward flexion and painless range of movement with approved normal acromiohumeral distance.

    42 Months

Study Arms (1)

Group I

Behavioral: Post-Op Follow Up

Interventions

Post Arthroscopic Biceps Tenotomy and Subacromial Decompression in Chronic Massive Rotator Cuff Tears.

Group I

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

From Oct 2018 to Jan 2021, 23 patients who had chronic massive RCTs received arthroscopic management for their RCTs and were followed as short-term follow-up for 3 months after surgery. Then, patients were asked to attend the Orthopedic outpatient clinic every three months for assessment to get the outcomes of the long-term follow-up. The preoperative, operative, immediate postoperative, and short-term follow-up data were collected from patients' files.

You may qualify if:

  • Patient who had arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears

You may not qualify if:

  • Patient who hadn't met the requirements for arthroscopic debridement with subacromial decompression and biceps tenotomy without rotator cuff repair for chronic massive Rotator Cuff Tears

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Kasr Al-Einy

Cairo, 11451, Egypt

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon, MSc Candidate

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 19, 2024

Study Start

November 19, 2018

Primary Completion

November 20, 2021

Study Completion

July 23, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations