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Completed

NCT Number: NCT03816436

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

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.

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Key information

Conditions

Clavicular Length

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedics, Basel, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Follow- up (FU) assessment

Other

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2019
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.