NCT03693716

Brief Summary

Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.3 years

First QC Date

September 30, 2018

Last Update Submit

February 27, 2023

Conditions

Anterior Shoulder DislocationBankart LesionHill Sachs Lesion

Keywords

TranssubscapularLong head of the biceps tendonLHBTAnterior Shoulder DislocationBankartHillSachsArthroscopic Anterior Dynamic Stabilization

Outcome Measures

Primary Outcomes (1)

  • Shoulder range of motion (ROM)

    Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.

    2 years

Secondary Outcomes (3)

  • Shoulder Strength

    2 years

  • The ROWE score

    2 years

  • The Western Ontario Shoulder Instability Index (WOSI)

    2 years

Study Arms (1)

Dynamic Anterior Stabilization

EXPERIMENTAL

Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis

Procedure: Dynamic Anterior Stabilization

Interventions

Dynamic Anterior StabilizationPROCEDURE

All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors

Dynamic Anterior Stabilization

Eligibility Criteria

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

You may qualify if:

  • Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging
  • one or more traumatic anterior shoulder dislocation episodes
  • contact or forced overhead sport or work activity

You may not qualify if:

  • proximal humerus fracture
  • rotator cuff tear requiring repair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar de Lisboa Ocidental

Lisbon, 1700-348, Portugal

Location

Related Publications (3)

  • Rowe CR, Patel D, Southmayd WW. The Bankart procedure: a long-term end-result study. J Bone Joint Surg Am. 1978 Jan;60(1):1-16.

    PMID: 624747RESULT

  • Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72. doi: 10.1177/03635465980260060501.

    PMID: 9850776RESULT

  • de Campos Azevedo C, Angelo AC. All-Suture Anchor Dynamic Anterior Stabilization Produced Successful Healing of the Biceps Tendon: A Report of 3 Cases. JBJS Case Connect. 2021 Feb 17;11(1). doi: 10.2106/JBJS.CC.20.00149.

    PMID: 33599463DERIVED

MeSH Terms

Conditions

Bankart Lesions

Condition Hierarchy (Ancestors)

Shoulder FracturesFractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Clara Azevedo, MD

    Centro Hospitalar de Lisboa Ocidental

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shoulder Surgery Unit Coordinator

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 3, 2018

Study Start

September 20, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)