NCT04584476

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
unknown

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

October 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 7, 2020

Last Update Submit

October 7, 2020

Conditions

Keywords

Irreparable Rotator Cuff TearsSuperior Capsular Reconstruction

Outcome Measures

Primary Outcomes (3)

  • American Shoulder and Elbow Surgeons (ASES) score

    A patient-reported outcome measurement

    2 year postoperatively

  • Acromiohumeral distance (AHD)

    measured in x-ray

    1 year postoperatively

  • retear rate

    measured in MRI

    1 year postoperatively

Study Arms (2)

SCR group

EXPERIMENTAL

underwent superior capsular reconstruction

Procedure: superior capsular reconstuction

Partial group

OTHER

underwent partial rotator cuff repair

Procedure: partial rotator cuff repair

Interventions

these patients underwent arthroscopic superior capsular reconstuction

SCR group

these patients underwent arthroscopic partial rotator cuff repair

Partial group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Irreparable Rotator Cuff Tears
  • underwent superior capsular reconstruction or partial repair
  • at least two years follow-up

You may not qualify if:

  • reparable Rotator Cuff Tears
  • underwent reverse total shoulder arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Chunyan Jiang

    Sports Medicine Service, Beijing Jishuitan hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhijun Zhang, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Sports Medicine Service of Beijing Jishuitan hospital

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2023

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share