Trochanteric and Subtrochanteric Hip FracturesNCT00621088
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
A study testing Intertan in people with Trochanteric and Subtrochanteric Hip Fractures and Treatment With a New Nail or a Sliding Hip Screw, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures). Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)? Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw
- What is being tested?
- Intertan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2008to Mar 2010
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.
Who cannot join
- Patients with pathologic fractures, patients already included with a fracture on the opposite side.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).
Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?
- Conditions
- Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw
- Being tested
- Intertan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntertanProcedure or surgery
Operations performed either with a Sliding Hip Screw or a nail (Intertan)
| Study group | Role | What they receive |
|---|---|---|
| Intertan | Active comparator | Not described Receives: Procedure: Intertan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative pain (VAS)(and functional mobility (TUG-test))
Measured: 1 week postoperative
Secondary outcomes (1)
Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trochanteric and Subtrochanteric Hip FracturesStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kjell Matre, MD, Principal investigator, Orthopaedic Department, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621088
- Sponsor's protocol ID
- 17972
- Status last verified
- Sep 2010
- First submitted
- 11 Feb 2008
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
- ClinicalTrials.gov ID
- NCT00621088
- Acronym / sponsor ID
- 17972
- Conditions
- Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 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.
This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).
Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intertan | Active comparator | Procedure: Intertan |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.
Key exclusion criteria (1 listed)
- Patients with pathologic fractures, patients already included with a fracture on the opposite side.
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 |
|---|---|---|
| IntertanOperations performed either with a Sliding Hip Screw or a nail (Intertan) | Procedure or surgery | Intertan |
Primary outcome
Early postoperative pain (VAS)(and functional mobility (TUG-test))
Time frame: 1 week postoperative
1 secondary outcome
Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.
Time frame: 1 year follow up
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 14 Sep 2010.
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.
Kjell Matre, MD principal investigator
Orthopaedic Department, Haukeland University 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 Intertan in people with Trochanteric and Subtrochanteric Hip Fractures and Treatment With a New Nail or a Sliding Hip Screw, run by Haukeland University 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 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: finished, as of the sponsor's last update on 14 Sep 2010. 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?
Early postoperative pain (VAS)(and functional mobility (TUG-test)) (time frame: 1 week postoperative). 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 14 Sep 2010.