Clinical Results of Arthroscopic Repair for Massive Rotat... | NCT04951375

Studies
Clinical Results of Arthroscopic Repair for Massive Rotator Cuff Tears of 14 Cases

NCT04951375

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Jul 6, 2021Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Rotator Cuff Tears

Interventions

arthroscopic repair

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Jun 1, 2018Actual

Completion Date

Jul 1, 2018Actual

First Submitted Date

Jun 17, 2021

First Submission Date that Met QC Criteria

Jun 25, 2021

First Posted Date

Jul 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2021

Last Update Posted Date

Jul 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study retrospectively analyzed data of 14 cases of massive rotator cuff tears who were treated with arthroscopic repair by the same doctor from October 2015 to December 2017, aiming to explore the surgical methods and clinical effects of arthroscopic repair for massive rotator cuff tears.

Detailed Description

The preoperative and intraoperative data and patient information of 14 cases of arthroscopic repair of huge rotator cuff tears performed by Deputy Chief Physician Yang Yuping of the Institute of Sports Medicine of Peking University Third Hospital from January 2016 to August 2017 sort out. Collect and organize follow-up data on the recovery and motor function of patients 6 months after surgery and the latest follow-up (February 4 to March 3, 2018). Discuss the operation method, and statistically analyze the short-term curative effect of patients undergoing the operation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Name	Type	Description	Arm Group Labels	Other Names
arthroscopic repair	Procedure	arthroscopic repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS	Pain visual analog scale	6 months after surgery
DASH	Arm, shoulder and hand dysfunction score	6 months after surgery
OSS	Oxford University Shoulder Score	6 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as massive rotator cuff tears and treated with arthroscopic repair from October, 2015 to December, 2017

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

From October, 2015 to December, 2017, 14 cases of massive rotator cuff tears who were treated with arthroscopic repair by the same doctor were included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuping Yang	Peking University Third Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Univerisity Third Hospital		Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D012421	Rupture
D014947	Wounds and Injuries
D000070599	Shoulder Injuries
D013708	Tendon Injuries

Browse Leaves

Not provided

Browse Branches

Not provided