Supracondylar Femur FractureLISSNCT00578019
Comparison Between LISS Plating and Intramedullary (IM) Nailing for Supracondylar Femur Fractures
A study testing IM Nailing and LISS in people with Supracondylar Femur Fracture, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar Nail (Smith \& Nephew Inc, Memphis, TN… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Supracondylar Femur Fracture
- What is being tested?
- IM Nailing and LISS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1999to May 2005
- 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
- Type A or C supracondylar femur fracture
- Adult patients (19 years or older)
Who cannot join
- Patients unable or unwilling to comply with follow-up gait, radiographic, and clinical evaluations necessary to complete the study
- Patients are not able or willing to give informed consent and/or have no responsible family member willing to give consent
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion or patients undergoing drug therapy that prevents bony healing
- Mentally retarded persons
- Mentally disabled individuals
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama at Birmingham, Orthopaedic Trauma
Birmingham, Alabama, 35294
About this study
Official title: Prospective Comparison Between Less Invasive Stabilization System (LISS) Plating and Intramedullary Nailing for the Treatment of Supracondylar Femur Fractures
The purpose of this study is to compare patient outcomes for the Less Invasive Stabilization System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar Nail (Smith \& Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.
Read the detailed description
All patients who meet the inclusion and exclusion criteria will be randomized into one of two treatment groups. Group A patients will be treated with retrograde intramedullary nailing of the fracture with supplemental screw fixation of the articular portion of the fracture if needed. The Richards supracondylar nail (Smith \& Nephew Richards, Memphis, TN, USA) will be utilized. Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA). Supplemental screw fixation of the articular portion of the fracture will occur, if needed. Postoperative care will not be any different than the postoperative care of any other patient undergoing internal fixation of a complex fracture around the knee and based on the patient's overall condition.
Surgical Protocol: After the anesthesia staff has administered general anesthesia, the patient will be positioned on the operating room table as described by the intraoperative technique guide or according to the patient's injury and the surgeon's preference. The patient will be prepped and draped in the usual and customary manner for orthopaedic procedures of the lower extremities. The image intensifier will be available for intraoperative fluoroscopy. The manufacturer's surgical technique guide will be used intraoperatively for implantation of the LISS device and the supracondylar nail. The surgical wound will be closed according to the surgeon's preference. A drainage device may be used if indicated. Routine dressings will be applied. In all instances, immediate postoperative radiographs will be taken to document adequate reduction and fixation. Neurovascular evaluation of the extremity will be performed and documented when the patient emerges from the anesthetic. The patient will be discharged from the recovery room to the postoperative unit when they have met discharge criteria. Routine postoperative orders will be followed until discharge from the hospital.
Patients will be followed in the orthopaedic clinic at predetermined intervals following surgery. The clinic visits will include anterior-posterior and lateral radiographs of the affected extremity and a clinical examination. The patient will also complete the SF-36 (Appendix 1) and a pain scale (Appendix 2). This data will be used to compare the outcomes obtained with the two devices. Clinical follow-up will occur at 2, 4, 8, 12, 18, 26, and 52 weeks following surgery. Radiographs will be obtained at 4, 8, 12, 18, 26, and 52 weeks postoperatively. Patients will complete pain scales at 4, 8, 12, 18, 26, and 52 weeks after surgery. Clinical outcomes will be evaluated at weeks 12, 26, and 52.
- Conditions
- Supracondylar Femur Fracture
- Being tested
- IM Nailing, LISS
- Keywords
- Comparative, Supracondylar Femur Fracture, Intramedullary nailing, Less Invasive Stabilization System (LISS) Plating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM NailingProcedure or surgery
Also called Smith & Nephew Supracondylar Nail
Patients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail.
LISSProcedure or surgery
Also called Synthes LISS
Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA).
| Study group | Role | What they receive |
|---|---|---|
| 1, A | Active comparator | Not described Receives: Procedure: IM Nailing |
| 2, B | Experimental | Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA). Receives: Procedure: LISS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is complete healing of the femur fracture
Measured: Clinical outcomes will be evaluated at weeks 12, 26, and 52
Secondary outcomes (1)
Secondary outcome is to compare the time and quality of healing of the femur fracture
Measured: Will be evaluated at weeks 12, 26 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startDec 1999
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Supracondylar Femur FractureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- James P Stannard, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578019
- Sponsor's protocol ID
- F990825010
- Other IDs
- AO Foundation FORK 99S83
- Acronym
- LISS
- Status last verified
- Sep 2013
- First submitted
- 18 Dec 2007
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kayali C, Agus H, Turgut A. Successful results of minimally invasive surgery for comminuted supracondylar femoral fractures with LISS: comparative study of multiply injured and isolated femoral fractures. J Orthop Sci. 2007 Sep;12(5):458-65. doi: 10.1007/s00776-007-1156-8. Epub 2007 Sep 28.
PubMed 17909931Boldin C, Fankhauser F, Hofer HP, Szyszkowitz R. Three-year results of proximal tibia fractures treated with the LISS. Clin Orthop Relat Res. 2006 Apr;445:222-9. doi: 10.1097/01.blo.0000203467.58431.a0.
PubMed 16456310Stannard JP, Wilson TC, Volgas DA, Alonso JE. The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results. J Orthop Trauma. 2004 Sep;18(8):552-8. doi: 10.1097/00005131-200409000-00012.
PubMed 15475852
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison Between Less Invasive Stabilization System (LISS) Plating and Intramedullary Nailing for the Treatment of Supracondylar Femur Fractures
- ClinicalTrials.gov ID
- NCT00578019
- Acronym / sponsor ID
- LISS / F990825010
- Conditions
- Supracondylar Femur Fracture
- Keywords
- Comparative, Supracondylar Femur Fracture, Intramedullary nailing, Less Invasive Stabilization System (LISS) Plating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 1999
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Dec 2007 (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 to compare patient outcomes for the Less Invasive Stabilization System (LISS) (Synthes {USA}, Paoli, PA, USA), a minimally invasive plating system used in the treatment of supracondylar femur fractures, with patient outcomes for the Supracondylar Nail (Smith \& Nephew Inc, Memphis, TN, USA), a retrograde intramedullary nail.
Detailed description
All patients who meet the inclusion and exclusion criteria will be randomized into one of two treatment groups. Group A patients will be treated with retrograde intramedullary nailing of the fracture with supplemental screw fixation of the articular portion of the fracture if needed. The Richards supracondylar nail (Smith \& Nephew Richards, Memphis, TN, USA) will be utilized. Group B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA). Supplemental screw fixation of the articular portion of the fracture will occur, if needed. Postoperative care will not be any different than the postoperative care of any other patient undergoing internal fixation of a complex fracture around the knee and based on the patient's overall condition.
Surgical Protocol: After the anesthesia staff has administered general anesthesia, the patient will be positioned on the operating room table as described by the intraoperative technique guide or according to the patient's injury and the surgeon's preference. The patient will be prepped and draped in the usual and customary manner for orthopaedic procedures of the lower extremities. The image intensifier will be available for intraoperative fluoroscopy. The manufacturer's surgical technique guide will be used intraoperatively for implantation of the LISS device and the supracondylar nail. The surgical wound will be closed according to the surgeon's preference. A drainage device may be used if indicated. Routine dressings will be applied. In all instances, immediate postoperative radiographs will be taken to document adequate reduction and fixation. Neurovascular evaluation of the extremity will be performed and documented when the patient emerges from the anesthetic. The patient will be discharged from the recovery room to the postoperative unit when they have met discharge criteria. Routine postoperative orders will be followed until discharge from the hospital.
Patients will be followed in the orthopaedic clinic at predetermined intervals following surgery. The clinic visits will include anterior-posterior and lateral radiographs of the affected extremity and a clinical examination. The patient will also complete the SF-36 (Appendix 1) and a pain scale (Appendix 2). This data will be used to compare the outcomes obtained with the two devices. Clinical follow-up will occur at 2, 4, 8, 12, 18, 26, and 52 weeks following surgery. Radiographs will be obtained at 4, 8, 12, 18, 26, and 52 weeks postoperatively. Patients will complete pain scales at 4, 8, 12, 18, 26, and 52 weeks after surgery. Clinical outcomes will be evaluated at weeks 12, 26, and 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, A | Active comparator | Procedure: IM Nailing |
| 2, B | Experimental | Procedure: LISSGroup B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type A or C supracondylar femur fracture
- Adult patients (19 years or older)
Key exclusion criteria (7 listed)
- Patients unable or unwilling to comply with follow-up gait, radiographic, and clinical evaluations necessary to complete the study
- Patients are not able or willing to give informed consent and/or have no responsible family member willing to give consent
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion or patients undergoing drug therapy that prevents bony healing
- Mentally retarded persons
- Mentally disabled individuals
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 |
|---|---|---|
| IM NailingAlso: Smith & Nephew Supracondylar NailPatients randomized to Arm 1, A will be treated with a retrograde intramedullary nailing of the femur fracture utilizing the Smith \& Nephew supracondylar nail. | Procedure or surgery | 1, A |
| LISSAlso: Synthes LISSGroup B patients will have their fracture stabilized with the LISS plates (Synthes [USA], Paoli, PA, USA). | Procedure or surgery | 2, B |
Primary outcome
The primary outcome measure is complete healing of the femur fracture
Time frame: Clinical outcomes will be evaluated at weeks 12, 26, and 52
1 secondary outcome
Secondary outcome is to compare the time and quality of healing of the femur fracture
Time frame: Will be evaluated at weeks 12, 26 and 52
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 1 Oct 2013.
- Background: PubMed 17909931Kayali C, Agus H, Turgut A. Successful results of minimally invasive surgery for comminuted supracondylar femoral fractures with LISS: comparative study of multiply injured and isolated femoral fractures. J Orthop Sci. 2007 Sep;12(5):458-65. doi: 10.1007/s00776-007-1156-8. Epub 2007 Sep 28.
- Background: PubMed 16456310Boldin C, Fankhauser F, Hofer HP, Szyszkowitz R. Three-year results of proximal tibia fractures treated with the LISS. Clin Orthop Relat Res. 2006 Apr;445:222-9. doi: 10.1097/01.blo.0000203467.58431.a0.
- Background: PubMed 15475852Stannard JP, Wilson TC, Volgas DA, Alonso JE. The less invasive stabilization system in the treatment of complex fractures of the tibial plateau: short-term results. J Orthop Trauma. 2004 Sep;18(8):552-8. doi: 10.1097/00005131-200409000-00012.
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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 P Stannard, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IM Nailing and LISS in people with Supracondylar Femur Fracture, run by University of Alabama at Birmingham at 1 site in United States.
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 7 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 1 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 United States. 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?
The primary outcome measure is complete healing of the femur fracture (time frame: Clinical outcomes will be evaluated at weeks 12, 26, and 52). 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 NCT00578019, which also lists 3 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 1 Oct 2013.