The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
23. april 2019 opdateret af: University Hospital, Basel, Switzerland
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
46
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Basel, Schweiz, 4031
- Department of Orthopaedics
-
Zürich, Schweiz, 8008
- Schulthess Klinik Zürich
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Follow- up (FU) assessment on clavicular non- union
clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting
|
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)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clavicula shortening (cm)
Tidsramme: 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).
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Constant Murley score (CS)
Tidsramme: 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.
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
|
Subjective shoulder pain (NRS)
Tidsramme: 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)
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
|
Subjective shoulder value (SSV)
Tidsramme: 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%?"
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
|
Simple shoulder test (SST)
Tidsramme: 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)
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
|
Quality of Life (QoL)
Tidsramme: 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.
|
one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Andreas Mueller, PD Dr. med, Orthopädische Universitätsklinik Basel
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. august 2018
Primær færdiggørelse (Faktiske)
25. september 2018
Studieafslutning (Faktiske)
25. september 2018
Datoer for studieregistrering
Først indsendt
22. januar 2019
Først indsendt, der opfyldte QC-kriterier
22. januar 2019
Først opslået (Faktiske)
25. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. april 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. april 2019
Sidst verificeret
1. april 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-00120; ch19Mueller
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