Pseudoarthrosis of the ClavicleCLAPSNCT04041258
"Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
A study testing pseudoarthrosis of clavicle in people with Pseudoarthrosis of the Clavicle, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pseudoarthrosis of the Clavicle
- What is being tested?
- pseudoarthrosis of clavicle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2019to 1 May 2021
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of pseudarthrosis intervention
- Males and Females
- Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute
Who cannot join
- Floating shoulder
- subjects who present contraindications to radiographic examination at the time of telephone contact
Trial locations and contacts
1 site in 1 country.
About this study
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle
Read the detailed description
The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute
- Conditions
- Pseudoarthrosis of the Clavicle
- Being tested
- pseudoarthrosis of clavicle
- Keywords
- pseudoarthrosis, clavicle
- Medical subject headings
- Clavicle, Pseudarthrosis Of, Congenital, Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pseudoarthrosis of clavicleProcedure or surgery
Pseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments.
| Study group | Role | What they receive |
|---|---|---|
| evaluation of clinical and radiographic findings after surgical treatment | Experimental | Evaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle Receives: Procedure: pseudoarthrosis of clavicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion ROM
improvement of range of motion measure (in grade)
Measured: at least 1 year of follow up
presence of dyskinesias
objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)
Measured: at least 1 year of follow up
alteration of the clavicle length
measure (mm) obtained from radiographic evaluation
Measured: at least 1 year of follow up
Secondary outcomes (1)
evaluate shoulder function
improvement in Assessment Shoulder and Elbow Scale (ASES) (0-100 points)
Measured: at least 1 year of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start30 Jul 2019
- Primary completion30 Jul 2020
- Study completion1 May 2021
Why it stopped: the number of patients was not sufficient to support continuation of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoarthrosis of the ClavicleStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041258
- Sponsor's protocol ID
- CLAPS
- Acronym
- CLAPS
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Clinical and Radiographic Results of Pseudarthrosis of Clavicle Treated With Plaque and Screws"
- ClinicalTrials.gov ID
- NCT04041258
- Acronym / sponsor ID
- CLAPS / CLAPS
- Conditions
- Pseudoarthrosis of the Clavicle
- Keywords
- pseudoarthrosis, clavicle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of patients was not sufficient to support continuation of the study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 1 Aug 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.
This is an interventional study for clinical and radiographic evaluation of patients operated for pseudoarthrosis of the clavicle
Detailed description
The aim of our study is to collect clinical and radiographic data from patients operated for pseudoarthrosis of the clavicle from 2007 to 2017 at the Rizzoli Orthopedic Institute, in order to evaluate the clinical and radiographic results of the treatment. This is an interventional study and patients will be contacted by telephone to verify their willingness to perform a visit (including a bilateral radiographic) at the Rizzoli Orthopedic Institute
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional study
| Arm | Type | Receives |
|---|---|---|
| evaluation of clinical and radiographic findings after surgical treatment | Experimental | Procedure: pseudoarthrosis of clavicleEvaluation of clinical and radiographic findings at least 1 year after surgical treatment for pseudoarthrosis of clavicle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of pseudarthrosis intervention
- Males and Females
- Patients treated for pseudoarthrosis of the clavicle between 2007 and 2017 at the Rizzoli Orthopedic Institute
Key exclusion criteria (2 listed)
- Floating shoulder
- subjects who present contraindications to radiographic examination at the time of telephone contact
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 |
|---|---|---|
| pseudoarthrosis of claviclePseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments. | Procedure or surgery | evaluation of clinical and radiographic findings after surgical treatment |
Primary outcome
range of motion ROM
Time frame: at least 1 year of follow up
improvement of range of motion measure (in grade)
presence of dyskinesias
Time frame: at least 1 year of follow up
objective clinical evaluation (elevation, external rotation, abduction) with constant scale (0-25 points)
alteration of the clavicle length
Time frame: at least 1 year of follow up
measure (mm) obtained from radiographic evaluation
1 secondary outcome
evaluate shoulder function
Time frame: at least 1 year of follow up
Results and safety
The study was stopped early (reason given: the number of patients was not sufficient to support continuation of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pseudoarthrosis of clavicle in people with Pseudoarthrosis of the Clavicle, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 2 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: stopped early, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 was stopped early (reason given: the number of patients was not sufficient to support continuation of the study). Results are not available in the source record.
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?
range of motion ROM (time frame: at least 1 year of follow up). The study lists 3 primary outcomes in all. 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 15 Apr 2022.