NCT03347019

Brief Summary

The aim of this study was to prospectively evaluate the efficacy of an accelerated rehabilitation regime for patients undergoing early arthroscopic stabilization for first-time anterior dislocation in terms of clinical outcome, return to play data and recurrence rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2019

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

November 6, 2017

Last Update Submit

April 17, 2020

Conditions

Bankart Lesion

Keywords

bankart repairaccelerated rehabilitationshoulder

Outcome Measures

Primary Outcomes (1)

  • 3 Dimensional Kinematic Analysis

    Scapular kinematic measurements were conducted by using three-dimensional electromagnetic system (Motion Monitor® Skeleton Analysis System, Innovative Sports Training Inc, Chicago, USA). The three-dimensional electromagnetic system consists of motion monitor software, transmitters and sensors integrated into this software (Flock of Birds System).

    at sixth months after surgery

Secondary Outcomes (4)

  • Pain Assessment

    at sixth months after surgery

  • First Functional Assessment

    at sixth months after surgery

  • Second Functional Assessment

    at sixth months after surgery

  • Third Functional Assessment

    at sixth months after surgery

Study Arms (2)

accelerated rehabilitation after surgery

EXPERIMENTAL

patients were included progressive rehabilitation programme first week after arthroscopic bankart repair consisting of passive shoulder range of motion exercises, scapular retraction exercises. The exercise programme progressed from active range of motion exercises to resistive and plyometric shoulder exercises. Patients were followed for six months.

Other: Accelerated rehabilitation

delayed rehabilitation after surgery

EXPERIMENTAL

Patients were not allowed to start passive shoulder exercises first three weeks after surgery. Patients were included progressive rehabilitation programme third week after arthroscopic bankart repair consisting of passive shoulder range of motion exercises, scapular retraction exercises. The exercise programme progressed from active range of motion exercises to resistive and plyometric shoulder exercises. Patients were followed for six months.

Other: Delayed rehabilitation

Interventions

Accelerated rehabilitationOTHER

advances in arthroscopic surgery have resulted in biomechanically stronger repairs that might allow for accelerated rehabilitation protocols and hence faster return to daily living activities and scapular control

accelerated rehabilitation after surgery
Delayed rehabilitationOTHER

Patients were not allowed to start rehabilitation programme first three weeks after surgery.

delayed rehabilitation after surgery

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient were included based on their history of a clear mechanism of injury resulting in traumatic anterior dislocation, with clear evidence of labral injury confirmed on magnetic resonance imaging.

You may not qualify if:

  • patients with inflammatory, autoimmune, endocrine or kidney diseases
  • Recurrence
  • Bony Bankart Lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bankart Lesions

Condition Hierarchy (Ancestors)

Shoulder FracturesFractures, BoneWounds and InjuriesShoulder Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 20, 2017

Study Start

December 15, 2016

Primary Completion

March 15, 2018

Study Completion

March 15, 2019

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

TU(1)