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NCT04584476 Clinical Trial

Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears

Rotator Cuff Tears Clinical Trial

Official title:
Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears: A Prospective Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04584476
Other study ID # CJiang-SCR
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2020
Est. completion date October 2023

Study information
Verified date October 2020
Source Beijing Jishuitan Hospital
Contact Zhijun Zhang, M.D.
Phone +86 15201277648
Email zzj5285029@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rotator cuff tear is one of the common injuries that cause shoulder pain in the elderly. After the rotator cuff tendon is injured, repairing the torn rotator cuff tendon through arthroscopic surgery is an effective treatment that is currently widely used. In the rotator cuff injury, irreparable rotator cuff injury is a difficult point in treatment, especially for patients with a long injury time, the obvious shrinkage of the injured tendon, muscle atrophy and steatosis may occur, all of which lead to the poor quality of the rotator cuff tendon needed to be repaired , Poor healing ability, seriously affecting the shoulder joint function and daily life of these patients. For this part of patients, arthroscopic partial repair of torn rotator cuffs is one of the commonly used methods. In addition, in recent years, superior capsular reconstruction has been gradually applied to the clinic and has achieved good clinical effects, but there are no controlled studies to compare Clinical effect of partial repair and superior capsular reconstruction on irreparable rotator cuff injury.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date October 2023
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- patients with Irreparable Rotator Cuff Tears

- underwent superior capsular reconstruction or partial repair

- at least two years follow-up

Exclusion Criteria:

- reparable Rotator Cuff Tears

- underwent reverse total shoulder arthroplasty

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• superior capsular reconstuction
these patients underwent arthroscopic superior capsular reconstuction
• partial rotator cuff repair
these patients underwent arthroscopic partial rotator cuff repair

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing Jishuitan Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary American Shoulder and Elbow Surgeons (ASES) score A patient-reported outcome measurement 2 year postoperatively
Primary Acromiohumeral distance (AHD) measured in x-ray 1 year postoperatively
Primary retear rate measured in MRI 1 year postoperatively
See also
  Status Clinical Trial Phase
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Recruiting NCT06055478 - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair N/A
Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Not yet recruiting NCT04047745 - Post-operative Exparel Study Following Rotator Cuff Repair N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A
Active, not recruiting NCT01586351 - Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection N/A