Back to results

Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

Primary Purpose

Displaced Midshaft Fracture of the Collar Bone

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Operation using a precontoured titanium plate and screws

Displaced midshaft fracture of the collar bone

About this trial

This is an interventional treatment trial for Displaced Midshaft Fracture of the Collar Bone focused on measuring Fracture, Collar bone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion Criteria:

bilateral fracture
imminent skin perforation
open fracture
associated neurovascular effect
unstable fracture of neck of scapula "floating shoulder"
fracture of coincidental upper extremity distal for the shoulder
pathologic fracture
the patient states that there was a unilateral or bilateral shoulder problem before the fracture
fracture realized more than 14 days after it arose
circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
medical contraindication against surgery or general anaesthesia
former participation in the trial
former fracture contra/ipsilateral at the age of 15 or older

Sites / Locations

Orthopaedic Division, Randers Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm sling treatment

Operation

Arm Description

Displaced midshaft fracture of the collar bone treated with an arm sling

Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand (DASH) Score

The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.

Secondary Outcome Measures

Constant-Murley Score

Full Information

NCT ID

NCT01078480

First Posted

February 27, 2010

Last Updated

January 21, 2016

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Central Jutland Regional Hospital, Vejle Hospital, Randers Regional Hospital, Swemac Orthopaedics ApS

1. Study Identification

Unique Protocol Identification Number

NCT01078480

Brief Title

Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

Official Title

Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Central Jutland Regional Hospital, Vejle Hospital, Randers Regional Hospital, Swemac Orthopaedics ApS

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws. The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Displaced Midshaft Fracture of the Collar Bone

Keywords

Fracture, Collar bone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm sling treatment

Arm Type

Experimental

Arm Description

Displaced midshaft fracture of the collar bone treated with an arm sling

Arm Title

Operation

Arm Type

Experimental

Arm Description

Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.

Intervention Type

Procedure

Intervention Name(s)

Operation using a precontoured titanium plate and screws

Other Intervention Name(s)

No other names.

Intervention Description

Operation using a precontoured titanium plate and screws

Intervention Type

Procedure

Intervention Name(s)

Displaced midshaft fracture of the collar bone

Other Intervention Name(s)

No other names.

Intervention Description

Displaced midshaft fracture of the collar bone treated with an arm sling

Primary Outcome Measure Information:

Title

Disabilities of the Arm, Shoulder and Hand (DASH) Score

Description

Time Frame

6 weeks, 3 months, 6 months, 1 year

Secondary Outcome Measure Information:

Title

Constant-Murley Score

Time Frame

6 weeks, 3 months, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels. Exclusion Criteria: bilateral fracture imminent skin perforation open fracture associated neurovascular effect unstable fracture of neck of scapula "floating shoulder" fracture of coincidental upper extremity distal for the shoulder pathologic fracture the patient states that there was a unilateral or bilateral shoulder problem before the fracture fracture realized more than 14 days after it arose circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration medical contraindication against surgery or general anaesthesia former participation in the trial former fracture contra/ipsilateral at the age of 15 or older

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carsten M Jensen, M.D.Sci.

Organizational Affiliation

Orthopaedic Division, Central Jutland, Randers Hospital, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthopaedic Division, Randers Hospital

City

Randers

State/Province

Central Jutland

ZIP/Postal Code

8930

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

32675585

Citation

Qvist AH, Vaesel MT, Jensen CM, Jakobsen T, Jensen SL. Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion. Clin Orthop Relat Res. 2021 Jan 1;479(1):129-138. doi: 10.1097/CORR.0000000000001411.

Results Reference

derived

Learn more about this trial

Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

We'll reach out to this number within 24 hrs