Tibial FracturesSP-PilotNCT01341418
Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study
A study testing Suprapatellar approach and Infrapatellar approach in people with Tibial Fractures, run by Florida Orthopaedic Institute at 2 sites in United States.
Trial summary
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Suprapatellar approach and Infrapatellar approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
- Acute tibial fractures within 4 weeks of injury
- Closed or open tibial fractures after appropriate irrigation and debridement
- Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
- Skeletally mature patient
- Age 18 and above.
Who cannot join
- Tibial shaft fractures that require articular reconstruction with plates
- Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia
- Tibial plateau fractures
- Pilon fractures
- Periprosthetic fractures
- Non-unions
Show all 13Show fewer
- Prior knee surgery
- History of gout or rheumatoid or osteoarthritis
- Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
- Spinal injury
- Prisoner or high likelihood of incarceration
- Not likely to follow-up in the estimation of surgeon
- Pregnant females
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa General Hospital
Tampa, Florida, 33606
St. Josephs Hospital
Tampa, Florida, 33607
About this study
Official title: Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.
Read the detailed description
Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.
- Conditions
- Tibial Fractures
- Being tested
- Suprapatellar approach, Infrapatellar approach
- Keywords
- tibia, suprapatellar
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprapatellar approachProcedure or surgery
Also called semi-extended approach
Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
Infrapatellar approachProcedure or surgery
Also called standard tibial nailing approach
The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Suprapatellar approach | Active comparator | surgical approach for intramedullary nailing of the tibia Receives: Procedure: Suprapatellar approach |
| Infrapatellar approach | Active comparator | surgical approach for intramedullary nailing of the tibia Receives: Procedure: Infrapatellar approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual postoperative knee pain
A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.
Measured: 1 year
Secondary outcomes (3)
union/alignment of tibia
AP and lateral radiographs will be used to evaluate union/alignment of the tibia.
Measured: 3 months postoperatively
knee function
A Lysholm knee score will be used to evaluate knee function, as well as range of motion (ROM) measurements.
Measured: 6 months postoperatively
trochlear changes in the patello-femoral cartilage
Pre- and post-nailing arthroscopic photos and an MRI at 12 months postoperative will be used to evaluate trochlear changes.
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 posted25 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2014
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor
- Investigators
- Roy W Sanders, M.D., Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341418
- Sponsor's protocol ID
- SP-2676-3103
- Other IDs
- OTA 39
- Acronym
- SP-Pilot
- Status last verified
- Feb 2017
- First submitted
- 20 Apr 2011
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelbke MK, Coombs D, Powell S, DiPasquale TG. Suprapatellar versus infra-patellar intramedullary nail insertion of the tibia: a cadaveric model for comparison of patellofemoral contact pressures and forces. J Orthop Trauma. 2010 Nov;24(11):665-71. doi: 10.1097/BOT.0b013e3181f6c001.
PubMed 20926959
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Suprapatellar Versus Infrapatellar Tibial Nailing: A Pilot Study
- ClinicalTrials.gov ID
- NCT01341418
- Acronym / sponsor ID
- SP-Pilot / SP-2676-3103
- Conditions
- Tibial Fractures
- Keywords
- tibia, suprapatellar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Collaborators
- Orthopaedic Trauma Association
- Study start
- Apr 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 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.
This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.
Detailed description
Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapatellar approach | Active comparator | Procedure: Suprapatellar approachsurgical approach for intramedullary nailing of the tibia |
| Infrapatellar approach | Active comparator | Procedure: Infrapatellar approachsurgical approach for intramedullary nailing of the tibia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
- Acute tibial fractures within 4 weeks of injury
- Closed or open tibial fractures after appropriate irrigation and debridement
- Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
- Skeletally mature patient
Key exclusion criteria (13 listed)
- Tibial shaft fractures that require articular reconstruction with plates
- Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia
- Tibial plateau fractures
- Pilon fractures
- Periprosthetic fractures
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 |
|---|---|---|
| Suprapatellar approachAlso: semi-extended approachSuprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up. | Procedure or surgery | Suprapatellar approach |
| Infrapatellar approachAlso: standard tibial nailing approachThe Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up. | Procedure or surgery | Infrapatellar approach |
Primary outcome
residual postoperative knee pain
Time frame: 1 year
A Visual Analog Scale (VAS) will be used for knee pain, as well as a pain location diagram and a Lysholm knee score.
3 secondary outcomes
union/alignment of tibia
Time frame: 3 months postoperatively
knee function
Time frame: 6 months postoperatively
trochlear changes in the patello-femoral cartilage
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 14 Feb 2017.
- Background: PubMed 20926959Gelbke MK, Coombs D, Powell S, DiPasquale TG. Suprapatellar versus infra-patellar intramedullary nail insertion of the tibia: a cadaveric model for comparison of patellofemoral contact pressures and forces. J Orthop Trauma. 2010 Nov;24(11):665-71. doi: 10.1097/BOT.0b013e3181f6c001.
Related trials for Tibial Fractures
Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Roy W Sanders, M.D. principal investigator
Florida Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprapatellar approach and Infrapatellar approach in people with Tibial Fractures, run by Florida Orthopaedic Institute at 2 sites 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 6 inclusion and 13 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
residual postoperative knee pain (time frame: 1 year). 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 NCT01341418, which also lists 1 linked publication.
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 Feb 2017.