Hip FractureNCT00859378
Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures
A study testing Cemented semiendoprosthesis and non-cemented in people with Hip Fracture and Proximal Femoral Fracture, run by Kuopio University Hospital at 2 sites in Finland.
Trial summary
The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fracture, Proximal Femoral Fracture
- What is being tested?
- Cemented semiendoprosthesis and non-cemented
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesFinland
- Study dates
- Oct 2008to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A proximal femoral fracture
Who cannot join
- Rheumatoid arthritis
- Pathologic fracture
- Severe dementia (preventing the informed consent)
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Central Hospital of North Carelia
Joensuu, 80200
Kuopio University Hospital
Kuopio, 70100
About this study
Official title: A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients
The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.
- Conditions
- Hip Fracture, Proximal Femoral Fracture
- Being tested
- Cemented semiendoprosthesis, non-cemented
- Keywords
- Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented
- Medical subject headings
- Hip Fractures, Proximal Femoral Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cemented semiendoprosthesisDevice
Application of a cemented semiendoprosthesis (Basis, Smith \& Nephew)
non-cementedDevice
Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)
| Study group | Role | What they receive |
|---|---|---|
| 1 - cemented | Active comparator | Patients are treated with a cemented semiendoprosthesis Receives: Device: Cemented semiendoprosthesis |
| 2 - non-cemented | Active comparator | Patients are treated with a non-cemented semiendoprosthesis Receives: Device: non-cemented |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary mortality
Measured: 3 months
Secondary outcomes (1)
Prosthetic complications
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 posted11 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2014
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Finnish Research Foundation for Orthopaedics and Traumatology
- Responsible party
- Principal investigator, Tero Yli-Kyyny, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859378
- Sponsor's protocol ID
- KUH5203038
- Status last verified
- Apr 2015
- First submitted
- 10 Mar 2009
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients
- ClinicalTrials.gov ID
- NCT00859378
- Acronym / sponsor ID
- KUH5203038
- Conditions
- Hip Fracture, Proximal Femoral Fracture
- Keywords
- Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- The Finnish Research Foundation for Orthopaedics and Traumatology
- Study start
- Oct 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Mar 2009 (estimated)
- 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.
The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - cemented | Active comparator | Device: Cemented semiendoprosthesisPatients are treated with a cemented semiendoprosthesis |
| 2 - non-cemented | Active comparator | Device: non-cementedPatients are treated with a non-cemented semiendoprosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A proximal femoral fracture
Key exclusion criteria (3 listed)
- Rheumatoid arthritis
- Pathologic fracture
- Severe dementia (preventing the informed consent)
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 |
|---|---|---|
| Cemented semiendoprosthesisApplication of a cemented semiendoprosthesis (Basis, Smith \& Nephew) | Device | 1 - cemented |
| non-cementedPatients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.) | Device | 2 - non-cemented |
Primary outcome
Primary mortality
Time frame: 3 months
1 secondary outcome
Prosthetic complications
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cemented semiendoprosthesis and non-cemented in people with Hip Fracture and Proximal Femoral Fracture, run by Kuopio University Hospital at 2 sites in Finland.
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 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: status not confirmed, as of the sponsor's last update on 7 Apr 2015. 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 Finland. 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?
Primary mortality (time frame: 3 months). 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 7 Apr 2015.