Hip FracturesAFIFNCT02631824
Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment
A study testing open reduction and internal fixation, TFNA and Augmentation (Cement) in people with Hip Fractures, run by Hospital Infantil Universitario de San Jose at 2 sites in Colombia.
Trial summary
Randomized clinical trial to assess if the use of augmentation in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65 years or older 1 year after surgery Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- open reduction and internal fixation, TFNA and Augmentation (Cement)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesColombia
- Study dates
- Nov 2015to Dec 2017
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients arriving to the emergency department after sustaining a fragility hip fracture
- radiographic diagnosis of intertrochanteric fracture requiring open reduction and internal fixation
- patient willing to accept a 1-year follow-up
- signature of informed consent
Who cannot join
- polytrauma
- patients with a non-fragility hip fracture (high-energy trauma)
- hip fractures due to primary or metastatic tumours,
- open or periprosthetic hip fractures
- patients with history of organ transplantation and patients with severe dementia.
- patients with iatrogenic perforation into the hip joint during procedure
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites, 2 recruiting
- Recruiting
Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C.
Daniela Sanchez, MD, 573108621670, danielasanchez1989@gmail.com
Rodrigo F Pesantez, MD, 573106883199, rpesantez@gmail.com
- Recruiting
Hospital Infantil de San José
Bogotá, Bogota D.C.
Daniela Sanchez, MD, 573108621670, danielasanchez1989@gmail.com
Carlos M Olarte, MD, 573158546947, cmolarte@hotmail.com
About this study
Official title: Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment: A Randomized Multicenter Clinical Trial
Randomized clinical trial to assess if the use of augmentation in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65 years or older 1 year after surgery
Read the detailed description
To determine if the use of augmentation with PMMA in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in osteoporotic patients, investigators aim to conduct a multicentered, randomized, single-blinded clinical trial.
All patients aged 65 years or older arriving to the emergency department of two level-1 trauma centers in Bogotá, Colombia; Hospital Universitario Fundación Santa Fe de Bogotá and Hospital Infantil Universitario de San José, after sustaining a fragility intertrochanteric hip fracture that requires open reduction and internal fixation (ORIF) will be included. These patients must be willing to accept a 1-year follow-up and are required to sign an informed consent agreeing to their participation in the study. For the sample calculation a two-tailed analysis with an alpha-level of significance of 0.05, a power of 80% (β = 0.2) was performed. A total of 35 patients per group plus a 30% increase to control for loss of follow-up was calculated. This gives a total of 90 patients; 45 patients per group.
Patients meeting inclusion and exclusion criteria will be recruited by convenience sampling as they arrive to the emergency department.
Once included in the study, patients will be stratified by age into two groups: patients aged between 65-85 years and patients over 85 years. Then, by using a block randomization, the intervention (augmentation) will be randomly allocated in order to divide the sample population into an intervention group (ORIF + augmentation with PMMA) and a control group (ORIF without augmentation). Randomization will be carried out by the program "Sealed Envelope" (https://www.sealedenvelope.com) that generates a list with codes (each code representing one patient) and randomly assigns them to either the intervention or the control group. This list will be in custody of a research assistant who will not have any contact with patients during the trial's duration and will be in charge of writing the allocation of each code into a sealed, opaque envelope. Each envelope will be given to the surgeon during the procedure at the precise moment where augmentation is needed, revealing whether or not augmentation should be performed. Medical care will be based on Orthogeriatric Programs and surgeries will be performed by orthopaedic surgeons with a clinical fellowship in Orthopaedic Trauma. Patients will be blinded to treatment and will be seen on follow-up visits 15 days, one month, 3 months, 6 months, and 12 months after the procedure.
The primary outcome will be the change in TAD measurement 1 year after the surgical procedure. The functional differences between both groups will be measured as secondary outcomes. Outcomes (primary and secondary) will be measured during follow-up visits one month, 3 months, 6 months, and 12 months after the procedure.
Results will be analyzed using STATA ® Data Analysis and Statistical Software, version 13.1. The sample's demographic and baseline characteristics will be described using descriptive statistics. Continuous variables will be reported as arithmetic means while categorical variables will be reported as absolute values of frequencies and distribution. For the inferential analysis of the results, a Shapiro Wilk W-Test will be used to determine normality distribution of values. If normality assumptions are met, the change in TAD measurement will be analyzed with a student t-test. If not, its non-parametric analogue (Mann-Whitney U-test) will be used. For all other categorical variables, a X2 or Fisher's exact test will be used.
- Conditions
- Hip Fractures
- Being tested
- open reduction and internal fixation, TFNA, Augmentation (Cement)
- Keywords
- fragility fractures, hip fractures, augmentation, tip-apex distance
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open reduction and internal fixationProcedure or surgery
Open reduction and internal fixation using an intramedullary nail
TFNADevice
Trochanteric Femoral Nail Advance
Augmentation (Cement)Device
Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | open reduction and internal fixation TFNA Receives: Procedure: open reduction and internal fixation; Device: TFNA |
| Augmentation | Experimental | open reduction and internal fixation TFNA Augmentation (Cement) Receives: Procedure: open reduction and internal fixation; Device: TFNA; Device: Augmentation (Cement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TAD measurement
The TAD will be measured in the immediate postoperative hip x-ray, one month, 3 months, 6 months, and 12 months after the procedure.
Measured: immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.
Secondary outcomes (3)
Parker Mobility Score
determine the pre-injury level of mobility and evaluate the functional recovery during the follow-up period.
Measured: one month, 3 months, 6 months, and 12 months after the procedure.
EQ-5D Questionnaire
determine the health-related quality of life perceived by the patient, both before the injury and during the follow-up period
Measured: one month, 3 months, 6 months, and 12 months after the procedure.
Pain Visual Analogue Scale
subjective evaluation of pain intensity
Measured: one month, 3 months, 6 months, and 12 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hip 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Universitario de San Jose
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Santa Fe de Bogota
- Responsible party
- Principal investigator, Carlos Mario Olarte, Hospital Infantil Universitario de San Jose
- Investigators
- Carlos M Olarte, MD, Principal investigator, Head of Orthopaedic Department at Hospital Infantil de San José
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631824
- Sponsor's protocol ID
- HIPFX-001-AUGM
- Acronym
- AFIF
- Status last verified
- Sep 2016
- First submitted
- 5 Dec 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kammerlander C, Erhart S, Doshi H, Gosch M, Blauth M. Principles of osteoporotic fracture treatment. Best Pract Res Clin Rheumatol. 2013 Dec;27(6):757-69. doi: 10.1016/j.berh.2014.02.005.
PubMed 24836334Simunovic N, Devereaux PJ, Sprague S, Guyatt GH, Schemitsch E, Debeer J, Bhandari M. Effect of early surgery after hip fracture on mortality and complications: systematic review and meta-analysis. CMAJ. 2010 Oct 19;182(15):1609-16. doi: 10.1503/cmaj.092220. Epub 2010 Sep 13.
PubMed 20837683Friedman SM, Mendelson DA, Kates SL, McCann RM. Geriatric co-management of proximal femur fractures: total quality management and protocol-driven care result in better outcomes for a frail patient population. J Am Geriatr Soc. 2008 Jul;56(7):1349-56. doi: 10.1111/j.1532-5415.2008.01770.x. Epub 2008 May 22.
PubMed 18503520Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
PubMed 1421796Giannoudis PV, Schneider E. Principles of fixation of osteoporotic fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1272-8. doi: 10.1302/0301-620X.88B10.17683.
PubMed 17012413Moroni A, Larsson S, Hoang Kim A, Gelsomini L, Giannoudis PV. Can we improve fixation and outcomes? Use of bone substitutes. J Orthop Trauma. 2009 Jul;23(6):422-5. doi: 10.1097/BOT.0b013e3181771426.
PubMed 19550228Kammerlander C, Gebhard F, Meier C, Lenich A, Linhart W, Clasbrummel B, Neubauer-Gartzke T, Garcia-Alonso M, Pavelka T, Blauth M. Standardised cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicentre trial. Injury. 2011 Dec;42(12):1484-90. doi: 10.1016/j.injury.2011.07.010. Epub 2011 Aug 19.
PubMed 21855063Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, Garcia-Alonso M, Nistal J, Blauth M. Long-term results of the augmented PFNA: a prospective multicenter trial. Arch Orthop Trauma Surg. 2014 Mar;134(3):343-9. doi: 10.1007/s00402-013-1902-7. Epub 2013 Dec 3.
PubMed 24297215Sermon A, Hofmann-Fliri L, Richards RG, Flamaing J, Windolf M. Cement augmentation of hip implants in osteoporotic bone: how much cement is needed and where should it go? J Orthop Res. 2014 Mar;32(3):362-8. doi: 10.1002/jor.22522. Epub 2013 Nov 20.
PubMed 24259367Eriksson F, Mattsson P, Larsson S. The effect of augmentation with resorbable or conventional bone cement on the holding strength for femoral neck fracture devices. J Orthop Trauma. 2002 May;16(5):302-10. doi: 10.1097/00005131-200205000-00003.
PubMed 11972072Augat P, Rapp S, Claes L. A modified hip screw incorporating injected cement for the fixation of osteoporotic trochanteric fractures. J Orthop Trauma. 2002 May;16(5):311-6. doi: 10.1097/00005131-200205000-00004.
PubMed 11972073Mattsson P, Larsson S. Unstable trochanteric fractures augmented with calcium phosphate cement. A prospective randomized study using radiostereometry to measure fracture stability. Scand J Surg. 2004;93(3):223-8. doi: 10.1177/145749690409300310.
PubMed 15544079Lee PC, Hsieh PH, Chou YC, Wu CC, Chen WJ. Dynamic hip screws for unstable intertrochanteric fractures in elderly patients--encouraging results with a cement augmentation technique. J Trauma. 2010 Apr;68(4):954-64. doi: 10.1097/TA.0b013e3181c995ec.
PubMed 20386288Dall'Oca C, Maluta T, Moscolo A, Lavini F, Bartolozzi P. Cement augmentation of intertrochanteric fractures stabilised with intramedullary nailing. Injury. 2010 Nov;41(11):1150-5. doi: 10.1016/j.injury.2010.09.026. Epub 2010 Oct 6.
PubMed 20932521Baumgaertner MR, Solberg BD. Awareness of tip-apex distance reduces failure of fixation of trochanteric fractures of the hip. J Bone Joint Surg Br. 1997 Nov;79(6):969-71. doi: 10.1302/0301-620x.79b6.7949.
PubMed 9393914
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic and Clinical Outcomes of Augmentation in Fragility Intertrochanteric Hip Fracture Treatment: A Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02631824
- Acronym / sponsor ID
- AFIF / HIPFX-001-AUGM
- Conditions
- Hip Fractures
- Keywords
- fragility fractures, hip fractures, augmentation, tip-apex distance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Infantil Universitario de San JoseUniversity, hospital or other
- Collaborators
- Fundación Santa Fe de Bogota
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Dec 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.
Randomized clinical trial to assess if the use of augmentation in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in patients aged 65 years or older 1 year after surgery
Detailed description
To determine if the use of augmentation with PMMA in the treatment of fragility intertrochanteric hip fractures improves radiologic and clinical outcomes in osteoporotic patients, investigators aim to conduct a multicentered, randomized, single-blinded clinical trial.
All patients aged 65 years or older arriving to the emergency department of two level-1 trauma centers in Bogotá, Colombia; Hospital Universitario Fundación Santa Fe de Bogotá and Hospital Infantil Universitario de San José, after sustaining a fragility intertrochanteric hip fracture that requires open reduction and internal fixation (ORIF) will be included. These patients must be willing to accept a 1-year follow-up and are required to sign an informed consent agreeing to their participation in the study. For the sample calculation a two-tailed analysis with an alpha-level of significance of 0.05, a power of 80% (β = 0.2) was performed. A total of 35 patients per group plus a 30% increase to control for loss of follow-up was calculated. This gives a total of 90 patients; 45 patients per group.
Patients meeting inclusion and exclusion criteria will be recruited by convenience sampling as they arrive to the emergency department.
Once included in the study, patients will be stratified by age into two groups: patients aged between 65-85 years and patients over 85 years. Then, by using a block randomization, the intervention (augmentation) will be randomly allocated in order to divide the sample population into an intervention group (ORIF + augmentation with PMMA) and a control group (ORIF without augmentation). Randomization will be carried out by the program "Sealed Envelope" (https://www.sealedenvelope.com) that generates a list with codes (each code representing one patient) and randomly assigns them to either the intervention or the control group. This list will be in custody of a research assistant who will not have any contact with patients during the trial's duration and will be in charge of writing the allocation of each code into a sealed, opaque envelope. Each envelope will be given to the surgeon during the procedure at the precise moment where augmentation is needed, revealing whether or not augmentation should be performed. Medical care will be based on Orthogeriatric Programs and surgeries will be performed by orthopaedic surgeons with a clinical fellowship in Orthopaedic Trauma. Patients will be blinded to treatment and will be seen on follow-up visits 15 days, one month, 3 months, 6 months, and 12 months after the procedure.
The primary outcome will be the change in TAD measurement 1 year after the surgical procedure. The functional differences between both groups will be measured as secondary outcomes. Outcomes (primary and secondary) will be measured during follow-up visits one month, 3 months, 6 months, and 12 months after the procedure.
Results will be analyzed using STATA ® Data Analysis and Statistical Software, version 13.1. The sample's demographic and baseline characteristics will be described using descriptive statistics. Continuous variables will be reported as arithmetic means while categorical variables will be reported as absolute values of frequencies and distribution. For the inferential analysis of the results, a Shapiro Wilk W-Test will be used to determine normality distribution of values. If normality assumptions are met, the change in TAD measurement will be analyzed with a student t-test. If not, its non-parametric analogue (Mann-Whitney U-test) will be used. For all other categorical variables, a X2 or Fisher's exact test will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Procedure: open reduction and internal fixation, Device: TFNAopen reduction and internal fixation TFNA |
| Augmentation | Experimental | Procedure: open reduction and internal fixation, Device: TFNA, Device: Augmentation (Cement)open reduction and internal fixation TFNA Augmentation (Cement) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- patients arriving to the emergency department after sustaining a fragility hip fracture
- radiographic diagnosis of intertrochanteric fracture requiring open reduction and internal fixation
- patient willing to accept a 1-year follow-up
- signature of informed consent
Key exclusion criteria (6 listed)
- polytrauma
- patients with a non-fragility hip fracture (high-energy trauma)
- hip fractures due to primary or metastatic tumours,
- open or periprosthetic hip fractures
- patients with history of organ transplantation and patients with severe dementia.
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 |
|---|---|---|
| open reduction and internal fixationOpen reduction and internal fixation using an intramedullary nail | Procedure or surgery | Augmentation, Standard treatment |
| TFNATrochanteric Femoral Nail Advance | Device | Augmentation, Standard treatment |
| Augmentation (Cement)Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA). | Device | Augmentation |
Primary outcome
Change in TAD measurement
Time frame: immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.
The TAD will be measured in the immediate postoperative hip x-ray, one month, 3 months, 6 months, and 12 months after the procedure.
3 secondary outcomes
Parker Mobility Score
Time frame: one month, 3 months, 6 months, and 12 months after the procedure.
EQ-5D Questionnaire
Time frame: one month, 3 months, 6 months, and 12 months after the procedure.
Pain Visual Analogue Scale
Time frame: one month, 3 months, 6 months, and 12 months after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Background: PubMed 24836334Kammerlander C, Erhart S, Doshi H, Gosch M, Blauth M. Principles of osteoporotic fracture treatment. Best Pract Res Clin Rheumatol. 2013 Dec;27(6):757-69. doi: 10.1016/j.berh.2014.02.005.
- Background: PubMed 20837683Simunovic N, Devereaux PJ, Sprague S, Guyatt GH, Schemitsch E, Debeer J, Bhandari M. Effect of early surgery after hip fracture on mortality and complications: systematic review and meta-analysis. CMAJ. 2010 Oct 19;182(15):1609-16. doi: 10.1503/cmaj.092220. Epub 2010 Sep 13.
- Background: PubMed 18503520Friedman SM, Mendelson DA, Kates SL, McCann RM. Geriatric co-management of proximal femur fractures: total quality management and protocol-driven care result in better outcomes for a frail patient population. J Am Geriatr Soc. 2008 Jul;56(7):1349-56. doi: 10.1111/j.1532-5415.2008.01770.x. Epub 2008 May 22.
- Background: PubMed 1421796Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. doi: 10.1007/BF01623184.
- Background: PubMed 17012413Giannoudis PV, Schneider E. Principles of fixation of osteoporotic fractures. J Bone Joint Surg Br. 2006 Oct;88(10):1272-8. doi: 10.1302/0301-620X.88B10.17683.
- Background: PubMed 19550228Moroni A, Larsson S, Hoang Kim A, Gelsomini L, Giannoudis PV. Can we improve fixation and outcomes? Use of bone substitutes. J Orthop Trauma. 2009 Jul;23(6):422-5. doi: 10.1097/BOT.0b013e3181771426.
- Background: PubMed 21855063Kammerlander C, Gebhard F, Meier C, Lenich A, Linhart W, Clasbrummel B, Neubauer-Gartzke T, Garcia-Alonso M, Pavelka T, Blauth M. Standardised cement augmentation of the PFNA using a perforated blade: A new technique and preliminary clinical results. A prospective multicentre trial. Injury. 2011 Dec;42(12):1484-90. doi: 10.1016/j.injury.2011.07.010. Epub 2011 Aug 19.
- Background: PubMed 24297215Kammerlander C, Doshi H, Gebhard F, Scola A, Meier C, Linhart W, Garcia-Alonso M, Nistal J, Blauth M. Long-term results of the augmented PFNA: a prospective multicenter trial. Arch Orthop Trauma Surg. 2014 Mar;134(3):343-9. doi: 10.1007/s00402-013-1902-7. Epub 2013 Dec 3.
- Background: PubMed 24259367Sermon A, Hofmann-Fliri L, Richards RG, Flamaing J, Windolf M. Cement augmentation of hip implants in osteoporotic bone: how much cement is needed and where should it go? J Orthop Res. 2014 Mar;32(3):362-8. doi: 10.1002/jor.22522. Epub 2013 Nov 20.
- Background: PubMed 11972072Eriksson F, Mattsson P, Larsson S. The effect of augmentation with resorbable or conventional bone cement on the holding strength for femoral neck fracture devices. J Orthop Trauma. 2002 May;16(5):302-10. doi: 10.1097/00005131-200205000-00003.
- Background: PubMed 11972073Augat P, Rapp S, Claes L. A modified hip screw incorporating injected cement for the fixation of osteoporotic trochanteric fractures. J Orthop Trauma. 2002 May;16(5):311-6. doi: 10.1097/00005131-200205000-00004.
- Background: PubMed 15544079Mattsson P, Larsson S. Unstable trochanteric fractures augmented with calcium phosphate cement. A prospective randomized study using radiostereometry to measure fracture stability. Scand J Surg. 2004;93(3):223-8. doi: 10.1177/145749690409300310.
- Individual participant dataSharing planned: No
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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.
Carlos M Olarte, MD principal investigator
Head of Orthopaedic Department at Hospital Infantil de San José
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing open reduction and internal fixation, TFNA and Augmentation (Cement) in people with Hip Fractures, run by Hospital Infantil Universitario de San Jose at 2 sites in Colombia.
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 6 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 13 Sep 2016. 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 Colombia. 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 Daniela Sanchez, MD (573108621670, danielasanchez1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TAD measurement (time frame: immediate postoperative hip x-ray (starting point), at one month, 3 months, 6 months, and 12 months after the procedure.). 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 NCT02631824, which also lists 17 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 Sep 2016.