Operative or Conservative Treatment of Acute Acromioclavi... | NCT01725997

Studies
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation

NCT01725997

Sponsor

St Goran's Hospital

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

124Actual

Phase

Not Applicable

Conditions

Acromioclavicular Joint Dislocation

Interventions

hook plate
Physiotherapy

Countries

Sweden

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

Jan 2020

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

Nov 14, 2012Actual

Primary Completion Date

Jun 5, 2019Actual

Completion Date

Jun 5, 2019Actual

First Submitted Date

Oct 31, 2012

First Submission Date that Met QC Criteria

Nov 8, 2012

First Posted Date

Nov 14, 2012Estimated

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

Jan 26, 2020

Last Update Posted Date

Jan 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Operative treatment	Active Comparator	Operative treatment with hook plate.	Procedure: hook plate
Conservative treatment	Active Comparator	Physiotherapy	Other: Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hook plate	Procedure	Surgery with hook plate followed by physiotherapy	Operative treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Constant Score		change from Baseline in Constant Score at 24 months

Secondary Outcomes

Measure	Description	Time Frame
Disabilities of Arm, Shoulder and Hand function (QuickDASH)		change from Baseline in QuickDASH at 24 months

Other Outcomes

Measure	Description	Time Frame
Shoulder Pain and Disability Index (SPADI)		Change from baseline in SPADI at 24 months
Radiographs with and without weight	Position of the AC-joint will be measured at standard radiographs and weighted radiographs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
men and women 18-65 years and able to work
understand spoken and/or written Swedish or English language
be able to start treatment within 3 weeks from trauma
consent form signed

Exclusion Criteria:

earlier injury to, or surgery of either of the shoulders
simultaneous fracture of the clavicle or acromion
associates neurovascular injury
severe osteoporosis
open dislocation
open growth plate of the acromion
local skin damage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena Boström Windhamre	Capio St Gorans hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Capio St Gorans Hospital AB		Stockholm		SE-11281	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided