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ClaviclePhase 2/3NCT01199653

Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures

A Phase 2/3 study testing Operative treatment and Non-operative treatment with arm immobilised to a sling in people with Clavicle and Fracture, run by Helsinki University Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Clavicle, Fracture
What is being tested?
Operative treatment and Non-operative treatment with arm immobilised to a sling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFinland
Study dates
Aug 2004to Nov 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a completely displaced middle third clavicle fracture, no cortical contact between main fragments
  • fresh fracture, treatment within seven days after injury
  • age between 18 and 70 years
  • provided informed consent

Who cannot join

  • fracture was not dislocated
  • multiple injured patient
  • associated neurovascular injury, or suspicion of it
  • reduced cooperation
  • cancer or any severe illness impairing health
  • pathological fracture
Show all 13Show fewer
  • treatment seven days after injury
  • open fracture
  • corticosteroid or immunosuppressive medication
  • upper extremity fracture at same time
  • an earlier clavicle or shoulder region fracture
  • pregnancy
  • lack of consent

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Helsinki University Central Hospital, Töölö Hospital

    Helsinki, Uusimaa, 00260

Other trials in Finland

About this study

Official title: Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Read the detailed description

Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.

There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Conditions
Clavicle, Fracture
Being tested
Operative treatment, Non-operative treatment with arm immobilised to a sling
Keywords
clavicle fractures, midshaft, dislocated, operative treatment, conservative treatment, non-operative treatment, randomized controlled trial, bone plates
Medical subject headings
Fractures, Bone, Joint Dislocations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Operative treatmentProcedure or surgery

    Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.

  • Non-operative treatment with arm immobilised to a slingProcedure or surgery

    Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

Study groups in NCT01199653
Study groupRoleWhat they receive
Non-operative treatmentActive comparatorNon-operative (conservative) treatment of the clavicle fracture
Receives: Procedure: Non-operative treatment with arm immobilised to a sling
Operative treatmentActive comparatorOperative stabilization (i.e. ORIF) of the fracture with a plate and screws.
Receives: Procedure: Operative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    Measured: Three months

  2. Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    Measured: One year

  3. Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    Measured: Two years

Secondary outcomes (12)

  1. Disability of the Arm, Shoulder and Hand (DASH)

    The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.

    Measured: Three months

  2. Pain at rest and activity

    Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly.

    Measured: Three weeks

  3. Fracture healing

    Fracture healing is examined from Xray.

    Measured: Three months

  4. Complications

    Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation.

    Measured: Continous till two years

  5. Disability of the Arm, Shoulder and Hand (DASH)

    The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.

    Measured: One year

  6. Disabilities of the Arm, Shoulder and Hand (DASH)

    The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb.

    Measured: Two years

  7. Pain at rest and activity

    Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly.

    Measured: Six weeks

  8. Pain at rest and at activity

    Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly

    Measured: Three months

  9. Pain at rest and at activity

    Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly

    Measured: One year

  10. Pain at rest and at activity

    Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly

    Measured: Two years

  11. Fracture healing

    Fracture healing is examined from Xray.

    Measured: One year

  12. Fracture healing

    Fracture healing is examined from Xray.

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study startAug 2004
  3. Primary completionOct 2007
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01199653
Sponsor's protocol ID
TYH6267
Other IDs
T102020Z12
Status last verified
Sep 2010
First submitted
10 Sep 2010
Last updated
13 Sep 2010
Results posted
No
Data monitoring committee
No

Publications

  • Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.

    PubMed 17200303

  • Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. doi: 10.1302/0301-620x.79b4.7529.

    PubMed 9250733

  • McKee MD, Seiler JG, Jupiter JB. The application of the limited contact dynamic compression plate in the upper extremity: an analysis of 114 consecutive cases. Injury. 1995 Dec;26(10):661-6. doi: 10.1016/0020-1383(95)00148-4.

    PubMed 8745801

  • NEER CS 2nd. Nonunion of the clavicle. J Am Med Assoc. 1960 Mar 5;172:1006-11. doi: 10.1001/jama.1960.03020100014003. No abstract available.

    PubMed 14426324

  • Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32.

    PubMed 8131324

  • Nowak J, Holgersson M, Larsson S. Can we predict long-term sequelae after fractures of the clavicle based on initial findings? A prospective study with nine to ten years of follow-up. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):479-86. doi: 10.1016/j.jse.2004.01.026.

    PubMed 15383801

  • Nowak J, Mallmin H, Larsson S. The aetiology and epidemiology of clavicular fractures. A prospective study during a two-year period in Uppsala, Sweden. Injury. 2000 Jun;31(5):353-8. doi: 10.1016/s0020-1383(99)00312-5.

    PubMed 10775691

  • Poigenfurst J, Rappold G, Fischer W. Plating of fresh clavicular fractures: results of 122 operations. Injury. 1992;23(4):237-41. doi: 10.1016/s0020-1383(05)80006-3.

    PubMed 1618563

  • Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.

    PubMed 16056089

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Operative treatment and Non-operative treatment with arm immobilised to a sling in people with Clavicle and Fracture, run by Helsinki University Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder function (time frame: Three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01199653, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2010.

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