Intertrochanteric FracturesPLAINNCT01344785
The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
An observational study of Intertrochanteric Fractures, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Intertrochanteric Fractures
- What is being tested?
- Intramedullary nailing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2010to Nov 2011
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden
Who may be able to join
- Intertrochanteric Fracture
- Age over 55
- Intramedullary nailing
Who cannot join
- Severe cognitive impairment
- Substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.
Read the detailed description
Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS).
Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.
- Conditions
- Intertrochanteric Fractures
- Being tested
- Intramedullary nailing
- Keywords
- Intertrochanteric Fractures, Intramedullary nailing, Hip function, Pain
- Medical subject headings
- Hip Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary nailingProcedure or surgery
Also called Gamma 3, Stryker, USA
All patients will be treated with Intramedullary nailing
| Study group | Role | What they receive |
|---|---|---|
| Patients with a intertrochanteric fracture | Patients with a intertrochanteric fracture, n=100 Receives: Procedure: Intramedullary nailing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip function
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 posted29 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Max Gordon, MD, Principal investigator, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344785
- Sponsor's protocol ID
- PLAIN-1
- Acronym
- PLAIN
- Status last verified
- Oct 2013
- First submitted
- 28 Apr 2011
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Loss of Offset After Pertrochanteric Fracture Treated With a Intramedullary Nail
- ClinicalTrials.gov ID
- NCT01344785
- Acronym / sponsor ID
- PLAIN / PLAIN-1
- Conditions
- Intertrochanteric Fractures
- Keywords
- Intertrochanteric Fractures, Intramedullary nailing, Hip function, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Apr 2011 (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 purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.
Detailed description
Intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. While severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. The current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (IM) nails and sliding hip screws (SHS).
Over the period 1998 to 2007 the use of IM nails for pertrochanteric fractures increased from 5% to 20% in Sweden, at the expense of the use of SHS (5). IM nailing has also become more common at our clinic where we since February 2008 use the 3rd generation of the Gamma nail. In this study we investigate if the increased pain after IM nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a intertrochanteric fracture | – | Procedure: Intramedullary nailingPatients with a intertrochanteric fracture, n=100 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 100 consecutive patients with an intertrochanteric fracture presenting at the Orthopaedic depertment of Danderyd Hospital, Sweden
Key inclusion criteria (3 listed)
- Intertrochanteric Fracture
- Age over 55
- Intramedullary nailing
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Substance abuse
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 |
|---|---|---|
| Intramedullary nailingAlso: Gamma 3, Stryker, USAAll patients will be treated with Intramedullary nailing | Procedure or surgery | Patients with a intertrochanteric fracture |
Primary outcome
Hip function
Time frame: 1 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 22 Oct 2013.
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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.
Max Gordon, MD principal investigator
Danderyd Hospital
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 Intertrochanteric Fractures, run by Danderyd Hospital at 1 site in Sweden.
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 3 inclusion and 2 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 22 Oct 2013. 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 Sweden. 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?
Hip function (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 22 Oct 2013.