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Clavicle FractureNCT05579873

Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures

An observational study of Clavicle Fracture, run by Luzerner Kantonsspital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clavicle Fracture
What is being tested?
Clavicle plating
Type of treatment
Surgery or procedure
How many people
336 participants
Where
No sites listed yet
Study dates
1 Nov 2022to 1 Oct 2025
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients (>18 older) presenting at the emergency department (ED) or outpatient clinic with midshaft clavicle fractures.

Who may be able to join

  • 18 years and older
  • Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2)
  • Patients that are eligible for operative treatment of clavicle fractures.
  • Generally accepted indications include:
  • Displacement of one or more shaft width
  • Shortening of more than 1cm in length
  • High demand patients (physical activity)

Who cannot join

  • Delayed presentation (> 14 days)
  • Initial operative treatment at non-participating hospitals
  • Open fractures
  • Pathological fractures
  • Re-fractures of clavicle
  • Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs)
  • Cognitive impairment or language barrier precluding answering questionnaires
  • Unable to complete follow-up (e.g. different residential area/tourists)

Trial locations and contacts

No sites are listed yet.

Frank Beeres, PhD/M.D. contact

0041412051914

frank.beeres@luks.ch

Bryan van de Wall, PhD/M.D. contact

0041412051914

bryan.vandewall@luks.ch

About this study

The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is:

  1. Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?
Read the detailed description

Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.

Being tested
Clavicle plating
Keywords
Clavicle/injuries, Bone Plates, Non-Randomized Controlled Trials as Topic
Medical subject headings
Wounds and Injuries

What participants receive

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

  • Clavicle platingProcedure or surgery

    VariAx 2.0mm + 2.4 or 2.7mm vs any other single plate

Study groups in NCT05579873
Study groupRoleWhat they receive
Single plating techniqueChoice of implant used for single plating left at descretion of treating surgeon.
Receives: Procedure: Clavicle plating
Double plating techniqueDouble plating consist of one VariAx 2.0mm plate positioned on the superior aspect of the clavicula and a second VariAx 2.4mm or 2.7 mm on the anterior side. Use of this implant will be according to the device's cleared indications of use.
Receives: Procedure: Clavicle plating

What is being measured

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

  1. Number of surgical re-interventions

    Any type of re-intervention (i.e. plate removal, screw adjustment etc.)

    Measured: 2 years follow-up

Secondary outcomes (12)

  1. Number of surgical re-interventions

    (including implant removal)

    Measured: 1 year follow-up

  2. Fracture realted infections

    According to metsemakers et al, 2018 (Metsemakers WJ, Morgenstern M, McNally et al., MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24. PMID: 28867644)

    Measured: 2 years follow-up

  3. Symptomatic non union

    defined as absence of radiological signs of healing (callus formation or fading of fracture lines) combined with pain at the fracture site at 12 months.

    Measured: 1 year follow-up

  4. Asymptomatic non-union

    defined as absence of radiological signs of healing (callus formation or fading of fracture lines) without any clinical symptoms.

    Measured: 1 year follow-up

  5. Numbness below scar line

    Tested postoperatively and at 12 months follow-up

    Measured: 1 year follow-up

  6. Self-reported implant irritation/implant prominence

    According to Hulsman et al, 2018 (17. Hulsmans M, van Heijl M, Houwert R, et al., Intramedullary nailing of displaced midshaft clavicle fractures using a TEN with end cap: issues encountered. Acta Orthop Belg. 2018 Dec;84(4):479-484. PMID: 30879453.)

    Measured: 1 year follow-up

  7. Operative time

    Measured: Baseline

  8. Length of surgical incision

    Length of surgical incision in cm

    Measured: basline

  9. DASH score

    The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

    Measured: baseline, 3- and 12-monts follow-up

  10. EQ-5D

    to monitor changes in self-reported health status through time in a given patient group

    Measured: baseline (pre-injury), 3- and 12-months follow-up

  11. VAS pain score

    Self-reported pain on a scale of 0 to 10.

    Measured: 3- and 12-months follow-up

  12. VAS for patient satisfaction

    Self-reported satisfaction on a scale of 0 to 10

    Measured: 3- and 12-months follow-up

Timeline

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

  1. First posted14 Oct 2022
  2. Study start1 Nov 2022 (estimated)
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
336 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05579873
Sponsor's protocol ID
2022-00574
Status last verified
Jul 2022
First submitted
11 Oct 2022
Last updated
17 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van der Meijden OA, Gaskill TR, Millett PJ. Treatment of clavicle fractures: current concepts review. J Shoulder Elbow Surg. 2012 Mar;21(3):423-9. doi: 10.1016/j.jse.2011.08.053. Epub 2011 Nov 6.

    PubMed 22063756

  • Robinson CM. Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br. 1998 May;80(3):476-84. doi: 10.1302/0301-620x.80b3.8079.

    PubMed 9619941

  • McKee RC, Whelan DB, Schemitsch EH, McKee MD. Operative versus nonoperative care of displaced midshaft clavicular fractures: a meta-analysis of randomized clinical trials. J Bone Joint Surg Am. 2012 Apr 18;94(8):675-84. doi: 10.2106/JBJS.J.01364.

    PubMed 22419410

  • Devji T, Kleinlugtenbelt Y, Evaniew N, Ristevski B, Khoudigian S, Bhandari M. Operative versus nonoperative interventions for common fractures of the clavicle: a meta-analysis of randomized controlled trials. CMAJ Open. 2015 Nov 10;3(4):E396-405. doi: 10.9778/cmajo.20140130. eCollection 2015 Oct-Dec.

    PubMed 26770963

  • Althausen PL, Shannon S, Lu M, O'Mara TJ, Bray TJ. Clinical and financial comparison of operative and nonoperative treatment of displaced clavicle fractures. J Shoulder Elbow Surg. 2013 May;22(5):608-11. doi: 10.1016/j.jse.2012.06.006. Epub 2012 Sep 7.

    PubMed 22960145

  • Chen MJ, DeBaun MR, Salazar BP, Lai C, Bishop JA, Gardner MJ. Safety and efficacy of using 2.4/2.4 mm and 2.0/2.4 mm dual mini-fragment plate combinations for fixation of displaced diaphyseal clavicle fractures. Injury. 2020 Mar;51(3):647-650. doi: 10.1016/j.injury.2020.01.014. Epub 2020 Jan 9.

    PubMed 31948781

  • Zhang F, Chen F, Qi Y, Qian Z, Ni S, Zhong Z, Zhang X, Li D, Yu B. Finite element analysis of dual small plate fixation and single plate fixation for treatment of midshaft clavicle fractures. J Orthop Surg Res. 2020 Apr 15;15(1):148. doi: 10.1186/s13018-020-01666-x.

    PubMed 32295608

  • Rompen IF, van de Wall BJM, van Heijl M, Bunter I, Diwersi N, Tillmann F, Migliorini F, Link BC, Knobe M, Babst R, Beeres FJP. Low profile dual plating for mid-shaft clavicle fractures: a meta-analysis and systematic review of observational studies. Eur J Trauma Emerg Surg. 2022 Aug;48(4):3063-3071. doi: 10.1007/s00068-021-01845-3. Epub 2022 Mar 2.

    PubMed 35237845

  • Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24.

    PubMed 28867644

  • Hulsmans M, van Heijl M, Houwert R, Verleisdonk EJ, Frima H. Intramedullary nailing of displaced midshaft clavicle fractures using a TEN with end cap: issues encountered. Acta Orthop Belg. 2018 Dec;84(4):479-484.

    PubMed 30879453

  • Germann G, Harth A, Wind G, Demir E. [Standardisation and validation of the German version 2.0 of the Disability of Arm, Shoulder,Hand (DASH) questionnaire]. Unfallchirurg. 2003 Jan;106(1):13-9. doi: 10.1007/s00113-002-0456-x. German.

    PubMed 12552388

  • Lecoultre Y, van de Wall BJM, Diwersi N, Pfarr SW, Galliker B, Babst R, Link BC, Beeres FJP. A natural experiment study: Low-profile double plating versus single plating techniques in midshaft clavicle fractures-Study protocol. PLoS One. 2023 Sep 8;18(9):e0291238. doi: 10.1371/journal.pone.0291238. eCollection 2023.

    PubMed 37683048

Questions about this trial

What is this clinical trial studying?

An observational study of Clavicle Fracture, run by Luzerner Kantonsspital.

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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

Results are not available in the source record.

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

Contact Frank Beeres, PhD/M.D. (0041412051914, frank.beeres@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of surgical re-interventions (time frame: 2 years follow-up). 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 NCT05579873, which also lists 12 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 17 Oct 2022.

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Clinical Trial NCT05579873 | AzTrials