Femoral FracturesTSPNCT00626470
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate
A study testing Addition of TSP to DHS in people with Femoral Fractures, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Addition of TSP to DHS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2008to Dec 2014
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
- (can include; Patients with cognitive problems (ie. dementia etc)
Who cannot join
- Patients with pathological fractures
- Multitrauma patients
- Patients not able to walk before the fracture
- Under 19 years old.
- Patients with fractures needing other treatments than gliding hip screws
- Reverse oblique fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.
- Conditions
- Femoral Fractures
- Being tested
- Addition of TSP to DHS
- Keywords
- Trochanter, Femur, Fracture
- Medical subject headings
- Femoral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of TSP to DHSProcedure or surgery
All patients operated with DHS. Of these two groups. One operated with TSP and one without.
| Study group | Role | What they receive |
|---|---|---|
| -TSP | Active comparator | Patients operated without TSP Receives: Procedure: Addition of TSP to DHS |
| +TSP | Active comparator | Patients operated with TSP Receives: Procedure: Addition of TSP to DHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture movement postoperatively
Measured: One year
Secondary outcomes (5)
Reoperation
Measured: One year
Pain postoperatively
Measured: one year
Hip function postoperatively
Measured: one year
Fracture healing
Measured: one year
complications postoperatively
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Haddon, MD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626470
- Sponsor's protocol ID
- TSP Study
- Acronym
- TSP
- Status last verified
- Sep 2017
- First submitted
- 15 Feb 2008
- Last updated
- 2 Oct 2017
- 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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate
- ClinicalTrials.gov ID
- NCT00626470
- Acronym / sponsor ID
- TSP / TSP Study
- Conditions
- Femoral Fractures
- Keywords
- Trochanter, Femur, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Feb 2008 (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.
Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| -TSP | Active comparator | Procedure: Addition of TSP to DHSPatients operated without TSP |
| +TSP | Active comparator | Procedure: Addition of TSP to DHSPatients operated with TSP |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
- (can include; Patients with cognitive problems (ie. dementia etc)
Key exclusion criteria (6 listed)
- Patients with pathological fractures
- Multitrauma patients
- Patients not able to walk before the fracture
- Under 19 years old.
- Patients with fractures needing other treatments than gliding hip screws
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 |
|---|---|---|
| Addition of TSP to DHSAll patients operated with DHS. Of these two groups. One operated with TSP and one without. | Procedure or surgery | +TSP, -TSP |
Primary outcome
Fracture movement postoperatively
Time frame: One year
5 secondary outcomes
Reoperation
Time frame: One year
Pain postoperatively
Time frame: one year
Hip function postoperatively
Time frame: one year
Fracture healing
Time frame: one year
complications postoperatively
Time frame: one year
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 2 Oct 2017.
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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.
James Haddon, MD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of TSP to DHS in people with Femoral Fractures, run by St. Olavs Hospital at 1 site in Norway.
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 2 inclusion and 6 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 2 Oct 2017. 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 Norway. 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?
Fracture movement postoperatively (time frame: One 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 2 Oct 2017.