Distal Femur FracturesNCT02475941
Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients
A study testing Non Weight bearing and Early Weight Bearing in people with Distal Femur Fractures, run by St. Louis University at 6 sites in United States.
Trial summary
The investigators will be looking at geriatric distal femur fractures. The investigators will prospectively enroll these patients and allow patients to either weight bear as tolerated or limit their weight bearing post operatively. The investigators will evaluate functional outcomes. Read more about this study
- Who is it for?
- Ages 64 to 90 years
- Conditions the study is for
- Distal Femur Fractures
- What is being tested?
- Non Weight bearing and Early Weight Bearing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- 11 May 2016to 27 Sep 2019
- 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 64 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal femur fractures, including periprosthetic fractures
- AO/OTA classification 33
- Above 64 years of age and below 90 years of age
- Household ambulators: defined as an individual who can walk continuously for distances that are considered reasonable for walking inside the home but limited for walking in the community due of endurance, strength, or safety concerns
Who cannot join
- Those who do not fit the inclusion criteria
- Concomitant ipsilateral lower extremity injury
- Contralateral lower extremity injury.
- Vascular injury of concomitant lower extremity requiring repair
- Pathologic fracture
- Definitive treatment delay of more than 2 weeks from initial injury
- Unable to comply with post-operative rehabilitation protocols or instructions
- Current or impending incarceration
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Wellstar
Atlanta, Georgia, 30312
Duke University
Durham, North Carolina, 27703
Grennville Health Sysytems
Greenville, South Carolina, 29604
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
St. Louis Medical Center
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
The investigators will be looking at geriatric distal femur fractures. The investigators will prospectively enroll these patients and allow patients to either weight bear as tolerated or limit their weight bearing post operatively. The investigators will evaluate functional outcomes.
Read the detailed description
Supracondylar femur fractures represent 4-7% of femur fractures. These are a common orthopaedic injury with an overall incidence of 37 per 100,000 person-years. These fractures are complex and challenging for orthopaedic surgeons. The fracture needs to be correctly reduced and, like nearly all fractures, fixed with enough stability to permit early joint motion. This allows for earlier patient rehabilitation, which can improve outcomes. There are a number of different fixation devices. Fixed angle implants such as retrograde intramedullary nails, angled blade plates, and 95-degree side plates have had good clinical outcomes with resistance to varus collapse. Recently, locking plates have become the standard method for distal femoral fracture fixation. Hendersen et al. provided a systematic review of locking plate fixation and demonstrated the range of complications as 0% to 32% and implant failure occurring late with 75% of failures occurring after 3 months and 50% occurring after 6 months. Ricci et al. sought to determine risk factors associated with failure of locked plate fixation of distal femur fractures and found that 19% required reoperation. The risk factors for reoperation found in this study were diabetes, smoking, increased body mass index, shorter plate length and open fracture. Most factors are out of surgeon control but are important to evaluate when considering prognosis.
After the fracture has been open reduced and internally fixed, there is debate on postoperative management of weight bearing. Weight bearing following fixation is generally restricted for 6 to 12 weeks until radiologic evidence of evidence demonstrates sufficient callous. This restricted weight bearing is primarily due to concerns of implant failure and loss of reduction. A study by Brumback et al. examined intramedullary nail fixation of distal femur fractures and concluded to allow full weight bearing of comminuted femoral shaft fractures with antegrade intramedullary nail. This study led surgeons to accelerate their rehabilitation protocols.
The post-operative weight bearing recommendations for distal femur fractures treated with locking plate vary widely which motivated Granata et al. to evaluate the biomechanics of immediate weight bearing of distal femur fractures treated with locked plate fixation. They found that the fatigue limit of the locked plate constructs was 1.9 times body weight for an average 70-kilogram patient over a simulated 10-week postoperative course. Although this study could not fully support immediate weight bearing due to the fact that femoral loads during gait have been estimated to be around 2 times body weight, it demonstrated adequate hardware fixation with weight bearing.
The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. The downside is the strength of fixation, the risk of implant failure, and the risk of loss of reduction. The goals are to evaluate the fracture, the complication rate, the mortality rate, and the risks of healthcare resources that have been used.
- Conditions
- Distal Femur Fractures
- Being tested
- Non Weight bearing, Early Weight Bearing
- Keywords
- geriatric fractures
- Medical subject headings
- Femoral Fractures, Distal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Weight bearingOther
The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).
The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient.
Early Weight BearingOther
The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).
The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Early Weight Bearing | Experimental | Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Early weight bearing are those who are permitted in the post operative instructions to be Weight Bear as tolerated after fracture fixation. Receives: Other: Early Weight Bearing |
| Non Weight Bearing | Active comparator | Surgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Non weight bearing are those who are NOT permitted in the post operative instructions to be Weight Bear after fracture fixation. Receives: Other: Non Weight bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture Healing in Early Weight Bearing assessed by radiographs
Will assess radiographs to assess for a healed fracture with no loss of fixation or need for secondary surgery
Measured: Post op-3 months
Secondary outcomes (3)
Visual Analog Scale to assess pain
Assess pain to compare between two groups
Measured: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Oxford Knee Score to measure knee function
Validated outcome measure to document knee function to compare between two groups
Measured: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
SF12 to measure return to function
Measures patients outcome based on their return to function.
Measured: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study start11 May 2016
- Primary completion2 Jan 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Distal Femur 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Place, MD, St. Louis University
- Investigators
- Howard Place, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475941
- Sponsor's protocol ID
- 24664
- Status last verified
- Nov 2019
- First submitted
- 4 Jun 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nieves JW, Bilezikian JP, Lane JM, Einhorn TA, Wang Y, Steinbuch M, Cosman F. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int. 2010 Mar;21(3):399-408. doi: 10.1007/s00198-009-0962-6. Epub 2009 May 30.
PubMed 19484169Zlowodzki M, Bhandari M, Marek DJ, Cole PA, Kregor PJ. Operative treatment of acute distal femur fractures: systematic review of 2 comparative studies and 45 case series (1989 to 2005). J Orthop Trauma. 2006 May;20(5):366-71. doi: 10.1097/00005131-200605000-00013.
PubMed 16766943David SM, Harrow ME, Peindl RD, Frick SL, Kellam JF. Comparative biomechanical analysis of supracondylar femur fracture fixation: locked intramedullary nail versus 95-degree angled plate. J Orthop Trauma. 1997 Jul;11(5):344-50. doi: 10.1097/00005131-199707000-00008.
PubMed 9294798Christodoulou A, Terzidis I, Ploumis A, Metsovitis S, Koukoulidis A, Toptsis C. Supracondylar femoral fractures in elderly patients treated with the dynamic condylar screw and the retrograde intramedullary nail: a comparative study of the two methods. Arch Orthop Trauma Surg. 2005 Mar;125(2):73-9. doi: 10.1007/s00402-004-0771-5. Epub 2004 Dec 21.
PubMed 15611863Hartin NL, Harris I, Hazratwala K. Retrograde nailing versus fixed-angle blade plating for supracondylar femoral fractures: a randomized controlled trial. ANZ J Surg. 2006 May;76(5):290-4. doi: 10.1111/j.1445-2197.2006.03714.x.
PubMed 16768683Ricci WM, Streubel PN, Morshed S, Collinge CA, Nork SE, Gardner MJ. Risk factors for failure of locked plate fixation of distal femur fractures: an analysis of 335 cases. J Orthop Trauma. 2014 Feb;28(2):83-9. doi: 10.1097/BOT.0b013e31829e6dd0.
PubMed 23760176Henderson CE, Kuhl LL, Fitzpatrick DC, Marsh JL. Locking plates for distal femur fractures: is there a problem with fracture healing? J Orthop Trauma. 2011 Feb;25 Suppl 1:S8-14. doi: 10.1097/BOT.0b013e3182070127.
PubMed 21248560Forster MC, Komarsamy B, Davison JN. Distal femoral fractures: a review of fixation methods. Injury. 2006 Feb;37(2):97-108. doi: 10.1016/j.injury.2005.02.015. Epub 2005 Apr 25.
PubMed 16439229Kregor PJ, Stannard JA, Zlowodzki M, Cole PA. Treatment of distal femur fractures using the less invasive stabilization system: surgical experience and early clinical results in 103 fractures. J Orthop Trauma. 2004 Sep;18(8):509-20. doi: 10.1097/00005131-200409000-00006.
PubMed 15475846Markmiller M, Konrad G, Sudkamp N. Femur-LISS and distal femoral nail for fixation of distal femoral fractures: are there differences in outcome and complications? Clin Orthop Relat Res. 2004 Sep;(426):252-7. doi: 10.1097/01.blo.0000141935.86481.ba.
PubMed 15346082Brumback RJ, Toal TR Jr, Murphy-Zane MS, Novak VP, Belkoff SM. Immediate weight-bearing after treatment of a comminuted fracture of the femoral shaft with a statically locked intramedullary nail. J Bone Joint Surg Am. 1999 Nov;81(11):1538-44. doi: 10.2106/00004623-199911000-00005.
PubMed 10565645Granata JD, Litsky AS, Lustenberger DP, Probe RA, Ellis TJ. Immediate weight bearing of comminuted supracondylar femur fractures using locked plate fixation. Orthopedics. 2012 Aug 1;35(8):e1210-3. doi: 10.3928/01477447-20120725-21.
PubMed 22868607McGraw P, Kumar A. Periprosthetic fractures of the femur after total knee arthroplasty. J Orthop Traumatol. 2010 Sep;11(3):135-41. doi: 10.1007/s10195-010-0099-6. Epub 2010 Jul 27.
PubMed 20661762Weinstein AM, Rome BN, Reichmann WM, Collins JE, Burbine SA, Thornhill TS, Wright J, Katz JN, Losina E. Estimating the burden of total knee replacement in the United States. J Bone Joint Surg Am. 2013 Mar 6;95(5):385-92. doi: 10.2106/JBJS.L.00206.
PubMed 23344005
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Weight Bearing on Supracondylar Distal Femur Fractures in Elderly Patients
- ClinicalTrials.gov ID
- NCT02475941
- Acronym / sponsor ID
- 24664
- Conditions
- Distal Femur Fractures
- Keywords
- geriatric fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 11 May 2016 (actual)
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 19 Jun 2015 (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 investigators will be looking at geriatric distal femur fractures. The investigators will prospectively enroll these patients and allow patients to either weight bear as tolerated or limit their weight bearing post operatively. The investigators will evaluate functional outcomes.
Detailed description
Supracondylar femur fractures represent 4-7% of femur fractures. These are a common orthopaedic injury with an overall incidence of 37 per 100,000 person-years. These fractures are complex and challenging for orthopaedic surgeons. The fracture needs to be correctly reduced and, like nearly all fractures, fixed with enough stability to permit early joint motion. This allows for earlier patient rehabilitation, which can improve outcomes. There are a number of different fixation devices. Fixed angle implants such as retrograde intramedullary nails, angled blade plates, and 95-degree side plates have had good clinical outcomes with resistance to varus collapse. Recently, locking plates have become the standard method for distal femoral fracture fixation. Hendersen et al. provided a systematic review of locking plate fixation and demonstrated the range of complications as 0% to 32% and implant failure occurring late with 75% of failures occurring after 3 months and 50% occurring after 6 months. Ricci et al. sought to determine risk factors associated with failure of locked plate fixation of distal femur fractures and found that 19% required reoperation. The risk factors for reoperation found in this study were diabetes, smoking, increased body mass index, shorter plate length and open fracture. Most factors are out of surgeon control but are important to evaluate when considering prognosis.
After the fracture has been open reduced and internally fixed, there is debate on postoperative management of weight bearing. Weight bearing following fixation is generally restricted for 6 to 12 weeks until radiologic evidence of evidence demonstrates sufficient callous. This restricted weight bearing is primarily due to concerns of implant failure and loss of reduction. A study by Brumback et al. examined intramedullary nail fixation of distal femur fractures and concluded to allow full weight bearing of comminuted femoral shaft fractures with antegrade intramedullary nail. This study led surgeons to accelerate their rehabilitation protocols.
The post-operative weight bearing recommendations for distal femur fractures treated with locking plate vary widely which motivated Granata et al. to evaluate the biomechanics of immediate weight bearing of distal femur fractures treated with locked plate fixation. They found that the fatigue limit of the locked plate constructs was 1.9 times body weight for an average 70-kilogram patient over a simulated 10-week postoperative course. Although this study could not fully support immediate weight bearing due to the fact that femoral loads during gait have been estimated to be around 2 times body weight, it demonstrated adequate hardware fixation with weight bearing.
The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. The downside is the strength of fixation, the risk of implant failure, and the risk of loss of reduction. The goals are to evaluate the fracture, the complication rate, the mortality rate, and the risks of healthcare resources that have been used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Weight Bearing | Experimental | Other: Early Weight BearingSurgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Early weight bearing are those who are permitted in the post operative instructions to be Weight Bear as tolerated after fracture fixation. |
| Non Weight Bearing | Active comparator | Other: Non Weight bearingSurgeon based prospective cohort supported in the literature to answer research questions in which surgeons have a preferred treatment type. Non weight bearing are those who are NOT permitted in the post operative instructions to be Weight Bear after fracture fixation. |
Who may qualify
- Ages
- 64 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Distal femur fractures, including periprosthetic fractures
- AO/OTA classification 33
- Above 64 years of age and below 90 years of age
- Household ambulators: defined as an individual who can walk continuously for distances that are considered reasonable for walking inside the home but limited for walking in the community due of endurance, strength, or safety concerns
Key exclusion criteria (8 listed)
- Those who do not fit the inclusion criteria
- Concomitant ipsilateral lower extremity injury
- Contralateral lower extremity injury.
- Vascular injury of concomitant lower extremity requiring repair
- Pathologic fracture
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 |
|---|---|---|
| Non Weight bearingThe design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing). The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. | Other | Non Weight Bearing |
| Early Weight BearingThe design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing). The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient. | Other | Early Weight Bearing |
Primary outcome
Fracture Healing in Early Weight Bearing assessed by radiographs
Time frame: Post op-3 months
Will assess radiographs to assess for a healed fracture with no loss of fixation or need for secondary surgery
3 secondary outcomes
Visual Analog Scale to assess pain
Time frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
Oxford Knee Score to measure knee function
Time frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
SF12 to measure return to function
Time frame: Pre-injury function and at 6 weeks, 3, 6 and 12 months post-injury
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 13 Nov 2019.
- Results publication: PubMed 19484169Nieves JW, Bilezikian JP, Lane JM, Einhorn TA, Wang Y, Steinbuch M, Cosman F. Fragility fractures of the hip and femur: incidence and patient characteristics. Osteoporos Int. 2010 Mar;21(3):399-408. doi: 10.1007/s00198-009-0962-6. Epub 2009 May 30.
- Results publication: PubMed 16766943Zlowodzki M, Bhandari M, Marek DJ, Cole PA, Kregor PJ. Operative treatment of acute distal femur fractures: systematic review of 2 comparative studies and 45 case series (1989 to 2005). J Orthop Trauma. 2006 May;20(5):366-71. doi: 10.1097/00005131-200605000-00013.
- Results publication: PubMed 9294798David SM, Harrow ME, Peindl RD, Frick SL, Kellam JF. Comparative biomechanical analysis of supracondylar femur fracture fixation: locked intramedullary nail versus 95-degree angled plate. J Orthop Trauma. 1997 Jul;11(5):344-50. doi: 10.1097/00005131-199707000-00008.
- Results publication: PubMed 15611863Christodoulou A, Terzidis I, Ploumis A, Metsovitis S, Koukoulidis A, Toptsis C. Supracondylar femoral fractures in elderly patients treated with the dynamic condylar screw and the retrograde intramedullary nail: a comparative study of the two methods. Arch Orthop Trauma Surg. 2005 Mar;125(2):73-9. doi: 10.1007/s00402-004-0771-5. Epub 2004 Dec 21.
- Results publication: PubMed 16768683Hartin NL, Harris I, Hazratwala K. Retrograde nailing versus fixed-angle blade plating for supracondylar femoral fractures: a randomized controlled trial. ANZ J Surg. 2006 May;76(5):290-4. doi: 10.1111/j.1445-2197.2006.03714.x.
- Results publication: PubMed 23760176Ricci WM, Streubel PN, Morshed S, Collinge CA, Nork SE, Gardner MJ. Risk factors for failure of locked plate fixation of distal femur fractures: an analysis of 335 cases. J Orthop Trauma. 2014 Feb;28(2):83-9. doi: 10.1097/BOT.0b013e31829e6dd0.
- Results publication: PubMed 21248560Henderson CE, Kuhl LL, Fitzpatrick DC, Marsh JL. Locking plates for distal femur fractures: is there a problem with fracture healing? J Orthop Trauma. 2011 Feb;25 Suppl 1:S8-14. doi: 10.1097/BOT.0b013e3182070127.
- Results publication: PubMed 16439229Forster MC, Komarsamy B, Davison JN. Distal femoral fractures: a review of fixation methods. Injury. 2006 Feb;37(2):97-108. doi: 10.1016/j.injury.2005.02.015. Epub 2005 Apr 25.
- Results publication: PubMed 15475846Kregor PJ, Stannard JA, Zlowodzki M, Cole PA. Treatment of distal femur fractures using the less invasive stabilization system: surgical experience and early clinical results in 103 fractures. J Orthop Trauma. 2004 Sep;18(8):509-20. doi: 10.1097/00005131-200409000-00006.
- Results publication: PubMed 15346082Markmiller M, Konrad G, Sudkamp N. Femur-LISS and distal femoral nail for fixation of distal femoral fractures: are there differences in outcome and complications? Clin Orthop Relat Res. 2004 Sep;(426):252-7. doi: 10.1097/01.blo.0000141935.86481.ba.
- Results publication: PubMed 10565645Brumback RJ, Toal TR Jr, Murphy-Zane MS, Novak VP, Belkoff SM. Immediate weight-bearing after treatment of a comminuted fracture of the femoral shaft with a statically locked intramedullary nail. J Bone Joint Surg Am. 1999 Nov;81(11):1538-44. doi: 10.2106/00004623-199911000-00005.
- Results publication: PubMed 22868607Granata JD, Litsky AS, Lustenberger DP, Probe RA, Ellis TJ. Immediate weight bearing of comminuted supracondylar femur fractures using locked plate fixation. Orthopedics. 2012 Aug 1;35(8):e1210-3. doi: 10.3928/01477447-20120725-21.
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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.
Howard Place, MD principal investigator
St. Louis University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Weight bearing and Early Weight Bearing in people with Distal Femur Fractures, run by St. Louis University at 6 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 4 inclusion and 8 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 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Fracture Healing in Early Weight Bearing assessed by radiographs (time frame: Post op-3 months). 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 NCT02475941, which also lists 14 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 13 Nov 2019.