Clavicular LengthNCT03816436
The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
An observational study of Clavicular Length, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clavicular Length
- What is being tested?
- Follow- up (FU) assessment
- How many people
- 46 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 17 Aug 2018to 25 Sep 2018
- 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: 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.
Who may be able to join
- 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
Who cannot join
- legal incompetence
- non- union of pathologic fractures
- current pregnancy
- German language barrier to complete questionnaires
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Orthopaedics
Basel, 4031
Schulthess Klinik Zürich
Zurich, 8008
About this study
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.
- Conditions
- Clavicular Length
- Being tested
- Follow- up (FU) assessment
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow- up (FU) assessmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Follow- up (FU) assessment on clavicular non- union | clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting Receives: Other: Follow- up (FU) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clavicula shortening (cm)
Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no).
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Secondary outcomes (5)
Constant Murley score (CS)
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.
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder pain (NRS)
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)
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder value (SSV)
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%?"
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Simple shoulder test (SST)
12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no)
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Quality of Life (QoL)
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.
Measured: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start17 Aug 2018
- Primary completion25 Sep 2018
- Study completion25 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicular LengthStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Mueller, PD Dr. med, Principal investigator, Orthopädische Universitätsklinik Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816436
- Sponsor's protocol ID
- 2018-00120; ch19Mueller
- Other IDs
- 2018
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2019
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
- ClinicalTrials.gov ID
- NCT03816436
- Acronym / sponsor ID
- 2018-00120; ch19Mueller
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 25 Sep 2018 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follow- up (FU) assessment on clavicular non- union | – | Other: Follow- up (FU) assessmentclavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- legal incompetence
- non- union of pathologic fractures
- current pregnancy
- German language barrier to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow- up (FU) assessmentFollow- 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) | Other | Follow- up (FU) assessment on clavicular non- union |
Primary outcome
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).
5 secondary outcomes
Constant Murley score (CS)
Time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder pain (NRS)
Time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Subjective shoulder value (SSV)
Time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Simple shoulder test (SST)
Time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Quality of Life (QoL)
Time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Mueller, PD Dr. med principal investigator
Orthopädische Universitätsklinik Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clavicular Length, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clavicula shortening (cm) (time frame: one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2019.