Femur FractureNCT00686023
Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
A study testing internal fixation (DHS - richard nail) and internal fixation (inflatable PFN by DISCOTEC) in people with Femur Fracture, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- internal fixation (DHS - richard nail) and internal fixation (inflatable PFN by DISCOTEC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Jan 2012
- 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
- Pertrochanteric femur fracture
- Unilateral
- Age over 60 years
- Low energy trauma
- ASA score 0-3
Who cannot join
- Reverse oblique fractures
- Pathological fractures
- Severe osteoarthritis of the hip joint
- Previous operations on same leg
- ASA score 4-5
Trial locations and contacts
1 site in 1 country.
Israel1 site
TASMC
Tel Aviv
eli steinberg, MD, 972-3-6974727, steinberge@tasmc.health.gov.il
About this study
Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.
Read the detailed description
patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.
group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.
weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)
outcomes: death within first year
postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation
- Conditions
- Femur Fracture
- Being tested
- internal fixation (DHS - richard nail), internal fixation (inflatable PFN by DISCOTEC)
- Keywords
- pertrochanteric femur fracture, DHS, IMN
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal fixation (DHS - richard nail)Procedure or surgery
Also called DHS - richard nail
internal fixation
internal fixation (inflatable PFN by DISCOTEC)Procedure or surgery
Also called inflatable PFN by DISCOTEC
internal fixation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | DHS fixation Receives: Procedure: internal fixation (DHS - richard nail) |
| 2 | Active comparator | IMN fixation Receives: Procedure: internal fixation (inflatable PFN by DISCOTEC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
death within 1 year of operation
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Eli Steinberg, MD, Principal investigator, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686023
- Sponsor's protocol ID
- TASMC-08-ES-0054
- Status last verified
- May 2008
- First submitted
- 27 May 2008
- Last updated
- 29 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Folman Y, Ron N, Shabat S, Hopp M, Steinberg E. Peritrochanteric fractures treated with the Fixion expandable proximal femoral nail: technical note and report of early results. Arch Orthop Trauma Surg. 2006 Apr;126(3):211-4. doi: 10.1007/s00402-006-0110-0. Epub 2006 Feb 24.
PubMed 16501984Lepore L, Lepore S, Maffulli N. Intramedullary nailing of the femur with an inflatable self-locking nail: comparison with locked nailing. J Orthop Sci. 2003;8(6):796-801. doi: 10.1007/s00776-003-0709-8.
PubMed 14648267Pajarinen J, Lindahl J, Michelsson O, Savolainen V, Hirvensalo E. Pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail. A randomised study comparing post-operative rehabilitation. J Bone Joint Surg Br. 2005 Jan;87(1):76-81.
PubMed 15686241Leung KS, So WS, Shen WY, Hui PW. Gamma nails and dynamic hip screws for peritrochanteric fractures. A randomised prospective study in elderly patients. J Bone Joint Surg Br. 1992 May;74(3):345-51. doi: 10.1302/0301-620X.74B3.1587874.
PubMed 1587874Hardy DC, Descamps PY, Krallis P, Fabeck L, Smets P, Bertens CL, Delince PE. Use of an intramedullary hip-screw compared with a compression hip-screw with a plate for intertrochanteric femoral fractures. A prospective, randomized study of one hundred patients. J Bone Joint Surg Am. 1998 May;80(5):618-30. doi: 10.2106/00004623-199805000-00002.
PubMed 9611022
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures
- ClinicalTrials.gov ID
- NCT00686023
- Acronym / sponsor ID
- TASMC-08-ES-0054
- Conditions
- Femur Fracture
- Keywords
- pertrochanteric femur fracture, DHS, IMN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 29 May 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.
Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.
Detailed description
patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.
group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.
weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)
outcomes: death within first year
postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: internal fixation (DHS - richard nail)DHS fixation |
| 2 | Active comparator | Procedure: internal fixation (inflatable PFN by DISCOTEC)IMN fixation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pertrochanteric femur fracture
- Unilateral
- Age over 60 years
- Low energy trauma
- ASA score 0-3
Key exclusion criteria (5 listed)
- Reverse oblique fractures
- Pathological fractures
- Severe osteoarthritis of the hip joint
- Previous operations on same leg
- ASA score 4-5
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 |
|---|---|---|
| internal fixation (DHS - richard nail)Also: DHS - richard nailinternal fixation | Procedure or surgery | 1 |
| internal fixation (inflatable PFN by DISCOTEC)Also: inflatable PFN by DISCOTECinternal fixation | Procedure or surgery | 2 |
Primary outcome
death within 1 year of operation
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2008.
- Results publication: PubMed 16501984Folman Y, Ron N, Shabat S, Hopp M, Steinberg E. Peritrochanteric fractures treated with the Fixion expandable proximal femoral nail: technical note and report of early results. Arch Orthop Trauma Surg. 2006 Apr;126(3):211-4. doi: 10.1007/s00402-006-0110-0. Epub 2006 Feb 24.
- Results publication: PubMed 14648267Lepore L, Lepore S, Maffulli N. Intramedullary nailing of the femur with an inflatable self-locking nail: comparison with locked nailing. J Orthop Sci. 2003;8(6):796-801. doi: 10.1007/s00776-003-0709-8.
- Results publication: PubMed 15686241Pajarinen J, Lindahl J, Michelsson O, Savolainen V, Hirvensalo E. Pertrochanteric femoral fractures treated with a dynamic hip screw or a proximal femoral nail. A randomised study comparing post-operative rehabilitation. J Bone Joint Surg Br. 2005 Jan;87(1):76-81.
- Results publication: PubMed 1587874Leung KS, So WS, Shen WY, Hui PW. Gamma nails and dynamic hip screws for peritrochanteric fractures. A randomised prospective study in elderly patients. J Bone Joint Surg Br. 1992 May;74(3):345-51. doi: 10.1302/0301-620X.74B3.1587874.
- Results publication: PubMed 9611022Hardy DC, Descamps PY, Krallis P, Fabeck L, Smets P, Bertens CL, Delince PE. Use of an intramedullary hip-screw compared with a compression hip-screw with a plate for intertrochanteric femoral fractures. A prospective, randomized study of one hundred patients. J Bone Joint Surg Am. 1998 May;80(5):618-30. doi: 10.2106/00004623-199805000-00002.
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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.
Eli Steinberg, MD principal investigator
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal fixation (DHS - richard nail) and internal fixation (inflatable PFN by DISCOTEC) in people with Femur Fracture, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 5 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 29 May 2008. 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 Israel. 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?
Contact Eli Steinberg, MD (972-3-6974727, steinberge@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death within 1 year of operation (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00686023, which also lists 5 linked publications.
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 29 May 2008.