Clavicle FractureNCT04343118
Benefit of Surgical Hardware Removal Following Clavicle Fracture
An observational study of Clavicle Fracture, run by Technical University of Munich at 1 site in Germany.
Trial summary
Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- Hardware Removal
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2015to 2 Jan 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requesting implant removal
Who may be able to join
- age >18 years
- Radiologically consolidated clavicle fracture
- following ORIF using a superior anatomically preformed locking plate
- asking for elective implant removal
- written informed consent.
Who cannot join
- Pregnancy
- Under-aged
- Delinquent patients.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675
About this study
Official title: Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial
Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
Read the detailed description
Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
Patients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ).
- Conditions
- Clavicle Fracture
- Being tested
- Hardware Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hardware RemovalProcedure or surgery
elective removal of plate osteosynthesis at the clavicle
| Study group | Role | What they receive |
|---|---|---|
| Group Removal | All patient receiving surgical removal of plate osteosynthesis Receives: Procedure: Hardware Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function
Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)
Measured: 6 Week post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Jan 2015
- Primary completion1 Jan 2020
- Study completion2 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chlodwig Kirchhoff, Technical University of Munich
- Investigators
- Chlodwig Kirchhoff, MD, Principal investigator, Klinikum rechts der Isar, TU München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343118
- Sponsor's protocol ID
- 089_2019ME
- Status last verified
- Apr 2020
- First submitted
- 1 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wurm M, Beirer M, Zyskowski M, Volk C, Schwarz A, Biberthaler P, Kirchhoff C, Cronlein M. Does implant removal of superior clavicle plate osteosynthesis affect the functional outcome: a prospective trial. Arch Orthop Trauma Surg. 2022 Jan;142(1):139-144. doi: 10.1007/s00402-020-03669-z. Epub 2020 Nov 1.
PubMed 33130933
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Patients Benefit From Elective Implant Removal Following Plate Osteosynthesis of Clavicle Fractures - a Prospective Trial
- ClinicalTrials.gov ID
- NCT04343118
- Acronym / sponsor ID
- 089_2019ME
- Conditions
- Clavicle Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 2 Jan 2020 (actual)
- First posted
- 13 Apr 2020 (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.
Little is known about the beneficial aspects of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
Detailed description
Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is general acceptance about the need of implant removal for obvious reasons, such as infections or implant failure, little is known about the beneficial aspects in cases of minor reasons. Therefore, we initiated this study to define patients' benefit of elective implant removal following plate osteosynthesis of displaced clavicle fractures.
Patients and Methods Prospective evaluation of patients was conducted before implant removal and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction, pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the Munich Shoulder Questionnaire (MSQ).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Removal | – | Procedure: Hardware RemovalAll patient receiving surgical removal of plate osteosynthesis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requesting implant removal
Key inclusion criteria (5 listed)
- age >18 years
- Radiologically consolidated clavicle fracture
- following ORIF using a superior anatomically preformed locking plate
- asking for elective implant removal
- written informed consent.
Key exclusion criteria (3 listed)
- Pregnancy
- Under-aged
- Delinquent patients.
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 |
|---|---|---|
| Hardware Removalelective removal of plate osteosynthesis at the clavicle | Procedure or surgery | Group Removal |
Primary outcome
Shoulder function
Time frame: 6 Week post surgery
Munich Shoulder Questionnaire allowing for calculation of Constant Score (0-100), Dash (0-100)
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 13 Apr 2020.
- Derived from this study: PubMed 33130933Wurm M, Beirer M, Zyskowski M, Volk C, Schwarz A, Biberthaler P, Kirchhoff C, Cronlein M. Does implant removal of superior clavicle plate osteosynthesis affect the functional outcome: a prospective trial. Arch Orthop Trauma Surg. 2022 Jan;142(1):139-144. doi: 10.1007/s00402-020-03669-z. Epub 2020 Nov 1.
- Individual participant dataSharing planned: No
Related trials for Clavicle Fracture
Recruiting
Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations
Clavicle Fracture
Active, not recruiting
Effectiveness of Superficial Cervical and Clavipectoral Block for Clavicle Surgery
Clavicle Fracture, Postoperative Pain
Enrolling by invitation
Cervical Plexus Versus Infiltration for Clavicular Operations (CERPICO)
Clavicle Surgery, Clavicle Fracture
Active, not recruiting
KT Tape for Pediatric Clavicle Fractures
Clavicle Fracture
Active, not recruitingObservational study
Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
Pseudarthrosis, Clavicle Fracture
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.
Chlodwig Kirchhoff, MD principal investigator
Klinikum rechts der Isar, TU München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clavicle Fracture, run by Technical University of Munich at 1 site in Germany.
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 5 inclusion and 3 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 13 Apr 2020. 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 Germany. 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?
Shoulder function (time frame: 6 Week post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343118, which also lists 1 linked publication.
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 13 Apr 2020.