Bone MetastasesNCT04940754
Ankle Arthrodesis Nail for 2-level Pathologic Tibial Fracture
A study testing osteosynthesis in people with Bone Metastases and Fracture Nonunion, run by Orthopaedie Zentrum Zuerich at 1 site in Switzerland.
Trial summary
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures Read more about this study
- Who is it for?
- Ages 80 to 90 years, women only
- Conditions the study is for
- Bone Metastases, Fracture Nonunion, Bone Lesion
- What is being tested?
- osteosynthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Apr 2021to 8 May 2022
- 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 80 to 90 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- old age, fragility fracture, tibia
Who cannot join
- active osteomyelitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures
Read the detailed description
The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,
- Conditions
- Bone Metastases, Fracture Nonunion, Bone Lesion
- Being tested
- osteosynthesis
- Keywords
- fragility fracture, old age
- Medical subject headings
- Fractures, Ununited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteosynthesisProcedure or surgery
Closed reduction, internal fixation
| Study group | Role | What they receive |
|---|---|---|
| Stabilzation of Fracture | Other | Arthrodesis nail used for stabilzation of a fracture, single patient Receives: Procedure: osteosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight bearing tolerance
Measuring walking distance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start8 Apr 2021
- Primary completion8 Apr 2022 (estimated)
- Study completion8 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- 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
- Use of an approved implant for expanded application
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopaedie Zentrum Zuerich
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940754
- Sponsor's protocol ID
- GUE
- Status last verified
- Aug 2021
- First submitted
- 10 Jun 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Arthrodesis Nail Combined With Locking Compression Plate to Stabilize Two-level Pathologic Tibial Fractures
- ClinicalTrials.gov ID
- NCT04940754
- Acronym / sponsor ID
- GUE
- Conditions
- Bone Metastases, Fracture Nonunion, Bone Lesion
- Keywords
- fragility fracture, old age
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Orthopaedie Zentrum ZuerichResearch network
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 8 Apr 2022 (estimated)
- Study completion
- 8 May 2022 (estimated)
- First posted
- 28 Jun 2021 (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.
Tibial pseudarthrosis in 83 year old patient suffering from pathologic fractures
Detailed description
The arthrodesis nail for hind foot problems is used as salvage for tibial fractures after failed plate fixation,
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of an approved implant for expanded application
| Arm | Type | Receives |
|---|---|---|
| Stabilzation of Fracture | Other | Procedure: osteosynthesisArthrodesis nail used for stabilzation of a fracture, single patient |
Who may qualify
- Ages
- 80 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- old age, fragility fracture, tibia
Key exclusion criteria (1 listed)
- active osteomyelitis
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 |
|---|---|---|
| osteosynthesisClosed reduction, internal fixation | Procedure or surgery | Stabilzation of Fracture |
Primary outcome
Weight bearing tolerance
Time frame: 1 year
Measuring walking distance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Related trials for Bone Metastases
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
RecruitingPhase 2
Personalized NK Cell Therapy in CBT
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia
RecruitingObservational study
clinIcal Efficacy and Safety of Incadronate in Breast Cancer With Bone Metastases
Breast Cancer, Bone Metastases
Active, not recruitingPhase 2
Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer
Castration-resistant Prostate Cancer, Metastatic Cancer
Not yet recruiting
Peri-Transplant Gecacitinib in Patients With Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Myelofibrosis, Primary Myelofibrosis (PMF)
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 osteosynthesis in people with Bone Metastases and Fracture Nonunion, run by Orthopaedie Zentrum Zuerich at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. 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 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?
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?
Weight bearing tolerance (time frame: 1 year). 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 17 Aug 2021.