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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03816436
Enrollment
46
Registered
2019-01-25
Start date
2018-08-17
Completion date
2018-09-25
Last updated
2019-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clavicular Length

Keywords

clavicle non-unions, plate treatment of clavicular fractures, cortical bone grafting of clavicular fractures, clavicular midshaft non- union, clavicular lateral non- union, clavicular shortening

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.

Interventions

OTHERFollow- 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)

Sponsors

University Hospital, Basel, Switzerland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clavicula shortening (cm)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone graftingClavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).

Secondary

MeasureTime frameDescription
Constant Murley score (CS)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone graftingtool 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.
Subjective shoulder pain (NRS)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone graftingPatient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain)
Subjective shoulder value (SSV)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone graftingbased on a single question answered subjectively by Patient: What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?
Simple shoulder test (SST)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)
Quality of Life (QoL)one assessment at least 24 months after clavicular surgery by plate and iliac crest bone graftingassessed 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026