NCT03261778

Brief Summary

In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint. The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 18, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

August 18, 2017

Last Update Submit

January 12, 2021

Conditions

Acromioclavicular Joint Dislocation

Outcome Measures

Primary Outcomes (8)

  • Shoulder function

    Constant-Score

    at 6 weeks

  • Shoulder function

    Constant-Score

    at 12 weeks

  • Shoulder function

    ASES-Score (American Shoulder and Elbow Score)

    at 1 week

  • Shoulder function

    ASES-Score (American Shoulder and Elbow Score)

    at 6 weeks

  • Shoulder function

    ASES-Score (American Shoulder and Elbow Score)

    at 12 weeks

  • Shoulder function

    Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

    at 1 week

  • Shoulder function

    Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

    at 6 weeks

  • Shoulder function

    Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

    at 12 weeks

Secondary Outcomes (3)

  • Degree of lateral clavicle dislocation

    at initial presentation

  • Degree of lateral clavicle dislocation

    at 6 weeks

  • Degree of lateral clavicle dislocation

    at 12 weeks

Study Arms (2)

Acromion 2.0 Brace

EXPERIMENTAL
Device: Acromion 2.0 Brace

Mitella Sling

ACTIVE COMPARATOR
Device: Acromion 2.0 Brace

Interventions

Acromion 2.0 BraceDEVICE

Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling

Acromion 2.0 BraceMitella Sling

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First acute acromioclavicular dislocation Rockwood Type III

You may not qualify if:

  • Previous injury to acromioclavicular Joint
  • Previous surgery of acromioclavicular Joint
  • Known hypersensitivity or allergy to fabric of investigational product
  • Pregnancy
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Orthopädische Universitätsklinik Basel

Basel, 4031, Switzerland

Location

Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

Solothurn, 4500, Switzerland

Location

Related Publications (4)

  • Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.

    PMID: 9728155BACKGROUND

  • Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31.

    PMID: 24178060BACKGROUND

  • Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23.

    PMID: 21344264BACKGROUND

  • Duffett RW, Duralde XA, Marcus RE. CORR Synthesis: What Is the Most Effective Treatment for Rockwood Type III Acromioclavicular Joint Dislocations? Clin Orthop Relat Res. 2023 May 1;481(5):1008-1013. doi: 10.1097/CORR.0000000000002545. Epub 2023 Jan 13. No abstract available.

    PMID: 36728233DERIVED

Study Officials

  • Näder Helmy, PD, MD

    Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

    STUDY CHAIR

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
Dr. med. Michael Finsterwald

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 25, 2017

Study Start

September 1, 2017

Primary Completion

December 31, 2020

Study Completion

January 12, 2021

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

CH(2)