NCT04952636

Brief Summary

To evaluate the clinical outcomes of arthroscopic and open Chinese Unique Inlay Bristow procedure in treating recurrent anterior shoulder instability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 27, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 6, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

December 9, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

June 27, 2021

Last Update Submit

November 28, 2021

Conditions

Shoulder Dislocation

Keywords

recurrent anterior shoulder dislocationBristow-Latarjet procedurearthroscopy

Outcome Measures

Primary Outcomes (2)

  • ASES score

    The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.

    2 years after surgery

  • pain VAS score

    The visual analog scale (VAS) for pain score is the most commonly used to describe pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

    2 years after surgery

Secondary Outcomes (4)

  • Active shoulder ranges of motion

    2 years after surgery

  • Bone block position

    immediately after surgery

  • Bone union

    3 months after surgery

  • Bone union

    2 years after surgery

Study Arms (2)

Arthroscopic Cuistow

EXPERIMENTAL

Patients who receive arthroscopic Cuistow procedure

Procedure: arthroscopic Cuistow

Open Cuistow

EXPERIMENTAL

Patients who receive open Cuistow procedure

Procedure: open Cuistow

Interventions

arthroscopic CuistowPROCEDURE

peforming the Cuistow Procedure under arthroscopy

Arthroscopic Cuistow
open CuistowPROCEDURE

peforming the Cuistow Procedure with the traditional open process

Open Cuistow

Eligibility Criteria

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

You may qualify if:

  • a glenoid defect ≥10%
  • contact sport athletes with a glenoid defect \< 10%
  • failure after Bankart repair.

You may not qualify if:

  • epilepsy
  • multidirectional shoulder instability
  • concomitant other lesions including rotator cuff tear, symptomatic acromioclavicular joint pathology or pathological involvement of the long head of the biceps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PekingUTH

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesShoulder Injuries

Study Officials

  • Guoqing Cui

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Shuhan Zhang

CONTACT

86-15336331337shuhan.zhang@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 7, 2021

Study Start

November 6, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2023

Last Updated

December 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)