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The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

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ClinicalTrials.gov Identifier: NCT03816436
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.

Condition or disease Intervention/treatment
Clavicular Length Other: Follow- up (FU) assessment

Study Design
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Study Type : Observational
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
Actual Study Start Date : August 17, 2018
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Groups and Cohorts
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Group/Cohort Intervention/treatment
Follow- up (FU) assessment on clavicular non- union
clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
 Other: Follow- up (FU) assessment
Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)


Outcome Measures
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Primary Outcome Measures :
  1. Clavicula shortening (cm) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).


Secondary Outcome Measures :
  1. Constant Murley score (CS) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    tool for assessment of shoulder function: Range of Motion (ROM) of shoulder (degree), abduction strength (kg), Quality of Life (QoL) questionnaire. The different scales are summed and normalized to 0=worst to 100=best.

  2. Subjective shoulder pain (NRS) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    Patient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain)

  3. Subjective shoulder value (SSV) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    based on a single question answered subjectively by Patient: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?"

  4. Simple shoulder test (SST) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)

  5. Quality of Life (QoL) [ Time Frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting ]
    assessed by Quality of Life EuroQoL 5D-5L Instrument (EQ-5D-5L); the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients surgically treated at the Schulthess Clinic (KWS) and at the University Hospital Basel (USB) for internal fixation with a plate and using iliac bone graft of clavicular non- unions.
Criteria

Inclusion Criteria:

  • clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
  • minimal follow- up of two years after surgery
  • written informed consent

Exclusion Criteria:

  • legal incompetence
  • non- union of pathologic fractures
  • current pregnancy
  • German language barrier to complete questionnaires
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03816436


Locations
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Switzerland
Department of Orthopaedics
Basel, Switzerland, 4031
Schulthess Klinik Zürich
Zürich, Switzerland, 8008
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Andreas Mueller, PD Dr. med Orthopädische Universitätsklinik Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03816436    
Other Study ID Numbers: 2018-00120; ch19Mueller
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
clavicle non-unions
plate treatment of clavicular fractures
cortical bone grafting of clavicular fractures
 clavicular midshaft non- union
clavicular lateral non- union
clavicular shortening
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries