Bone Diseases, InfectiousNCT03265561
Spinal Infection Management With Structural Allograft
A study testing Bone allograft and Bone auto and allograft group in people with Bone Diseases, Infectious and Disease of Bone, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Background. Bone infections can involve the vertebral column, intervertebral disc space, spinal canal and soft tissues, can generate neurological deficit in addition to the destruction of the bone that causes functional disability. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases, Infectious, Disease of Bone, Syndrome
- What is being tested?
- Bone allograft and Bone auto and allograft group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 14 May 2015to 15 Nov 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pyogenic spinal infection with bone destruction and spinal deformity, without previous treatment of any kind and Informed Consent signature
Who cannot join
- immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity
Trial locations and contacts
1 site in 1 country.
About this study
Background. Bone infections can involve the vertebral column, intervertebral disc space, spinal canal and soft tissues, can generate neurological deficit in addition to the destruction of the bone that causes functional disability. Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone debridement and bone reconstruction.
Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the spine after a bone spinal infection Material and methods. Patients with vertebral bone destruction are included in two groups. Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus autograft. The bone reconstruction will be performed in a one-time surgical procedure. Bone consolidation, pain, functionality, and spine deformity will be evaluated.
Read the detailed description
Spinal bone infections can involve the bone vertebra, intervertebral disc space, spinal canal and soft tissues. It generate neurological deficit in addition to the destruction of the bone that causes functional disability and significant pain (Colmenero 1997). Spinal infections include discitis, osteomyelitis, epidural abscesses, meningitis, subdural empyema, and abscesses of the spinal cord (An, 2006). Only discitis and osteomyelitis can occur together (Skaf, 2010). Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per 100,000 habitants (Bhavan, 2010; Grammatico 2003).
Pathogenic organisms reach the column by hematogenous pathway, arterial pathways (Batson's plexus) or by direct inoculation, due to a diagnostic or therapeutic intervention (Skaf, 2010). The natural history of pyogenic vertebral infections involves an infectious source or an incident followed by a period of intense pain, with or without generalized significant sepsis. Neurological deficit is caused by: [1] direct extension of the infection in the form of an abscess or bacterial communication with the spinal canal to the neural elements or [2] secondary compression of a pathological fracture as a result of bone softening. (Campbell´s, 2013).
Early diagnosis and treatment are essential for optimal outcomes (Weisz, 2000). The treatment goals may include eradicating the infection, relieving pain, preserving or restoring neurologic function, improving nutrition, and maintaining spinal stability (Tay, 2002). The aim of this study is to demonstrate that the use of bone allograft is a functional method to stabilize the spine after a bone spinal infection.
METHODS This study was approved by our Institutional Ethics and Research Committee. Patients with vertebral bone destruction are randomized included in two groups. Inclusion criteria: patients older than 18 years, any gender, pyogenic spinal infection with bone destruction and kyphotic deformity, without previous treatment of any kind, and Informed Consent signature. Exclusion criteria: patients with immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity. Elimination criteria: failure to comply with follow-up time, patient's express request to leave the study. The bone reconstruction will be performed in a one-step surgical procedure. All participants will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed guided by computed tomography (CT scan) and/or by fluoroscopy. A culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. The investigators will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram, and patients with infections with gram positive and negative microorganisms only will be included. Bone consolidation, pain, functionality, and spinal deformity will be evaluated.
The investigators will perform evaluations at 8, 12, 16, 20 and 24 weeks, and a CT scan will be realized, to evaluated the bone consolidation, defined as the presence of continuous trabeculae between the bone graft and the vertebra, according to the next classification system. Type 1 definitive fusion; Type 2 uncertain fusion; Type 3 definitive pseudoarthrosis.
Statistical analysis. The results will be reported in contingency tables, frequencies, percentages, measures of central tendency and dispersion. Qualitative variables will be analyzed with the chi-square statistic and quantitative variables with t-test for independent samples with a significance level of 95% with their respective confidence intervals, or with non-parametric statistics if necessary. Using a formula for hypothesis testing and difference of two proportions or with the proportion of a reference value, with a value zα of 1.94 with a level of significance of 95% for a queue, and a value zβ of 1.20 with a power of 80 %, With a proportion for group 1 of 0.38 and for group 2 of 0.83 (Zdeblick, Ducker) a sample of 19 participants was obtained per group. Statistical analysis will be performed with IBM SPSS version 20 (SPSS, Inc., Armon, NY).
- Conditions
- Bone Diseases, Infectious, Disease of Bone, Syndrome, Spine Infection, Allografts, Bone Graft; Complications, Fracture
- Being tested
- Bone allograft, Bone auto and allograft group
- Medical subject headings
- Bone Diseases, Infectious, Bone Diseases, Syndrome, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone allograftDevice
All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone allograft only.
Bone auto and allograft groupDevice
All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone autograft plus bone allograft
| Study group | Role | What they receive |
|---|---|---|
| Bone allograft group | Experimental | This participants will receive bone structural allograft management for vertebral reconstruction. All patients undergo surgical procedure to realize debridement of the lesion, and the application of allograft without autograft. Receives: Device: Bone allograft |
| Bone auto and allograft group | Active comparator | This participants will receive bone structural allograft plus spongy autograft management for vertebral reconstruction. All patients undergo surgical procedure. Receives: Device: Bone auto and allograft group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone consolidation
Radiography or CT scan will demonstrate bone graft consolidation
Measured: Twelve months
Secondary outcomes (3)
Pain scale
Visual Analogue Scale minimum 0 value = no pain; maximum 10 value= unsupportable pain
Measured: Three months
Oswestry Scale
Oswestry Lumbar Pain Disability Scale
Measured: Three months
Degree of spinal deformity
Radiographic measurement of Cobbs angle
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start14 May 2015
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bone Diseases, InfectiousStudies 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
- Model description
- Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus spongy autograft.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos A Acosta-Olivo, Universidad Autonoma de Nuevo Leon
- Investigators
- Carlos Acosta-Olivo, PhD, Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265561
- Sponsor's protocol ID
- OR15-005
- Status last verified
- Nov 2019
- First submitted
- 24 Aug 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Colmenero JD, Jimenez-Mejias ME, Sanchez-Lora FJ, Reguera JM, Palomino-Nicas J, Martos F, Garcia de las Heras J, Pachon J. Pyogenic, tuberculous, and brucellar vertebral osteomyelitis: a descriptive and comparative study of 219 cases. Ann Rheum Dis. 1997 Dec;56(12):709-15. doi: 10.1136/ard.56.12.709.
PubMed 9496149An HS, Seldomridge JA. Spinal infections: diagnostic tests and imaging studies. Clin Orthop Relat Res. 2006 Mar;444:27-33. doi: 10.1097/01.blo.0000203452.36522.97.
PubMed 16523124Skaf GS, Domloj NT, Fehlings MG, Bouclaous CH, Sabbagh AS, Kanafani ZA, Kanj SS. Pyogenic spondylodiscitis: an overview. J Infect Public Health. 2010;3(1):5-16. doi: 10.1016/j.jiph.2010.01.001. Epub 2010 Feb 19.
PubMed 20701886Bhavan KP, Marschall J, Olsen MA, Fraser VJ, Wright NM, Warren DK. The epidemiology of hematogenous vertebral osteomyelitis: a cohort study in a tertiary care hospital. BMC Infect Dis. 2010 Jun 7;10:158. doi: 10.1186/1471-2334-10-158.
PubMed 20529294Grammatico L, Baron S, Rusch E, Lepage B, Surer N, Desenclos JC, Besnier JM. Epidemiology of vertebral osteomyelitis (VO) in France: analysis of hospital-discharge data 2002-2003. Epidemiol Infect. 2008 May;136(5):653-60. doi: 10.1017/S0950268807008850. Epub 2007 Jun 14.
PubMed 17568478Govender S. Spinal infections. J Bone Joint Surg Br. 2005 Nov;87(11):1454-8. doi: 10.1302/0301-620X.87B11.16294. No abstract available.
PubMed 16260656Reihsaus E, Waldbaur H, Seeling W. Spinal epidural abscess: a meta-analysis of 915 patients. Neurosurg Rev. 2000 Dec;23(4):175-204; discussion 205. doi: 10.1007/pl00011954.
PubMed 11153548Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002 May-Jun;10(3):188-97. doi: 10.5435/00124635-200205000-00005.
PubMed 12041940Weisz RD, Errico TJ. Spinal infections. Diagnosis and treatment. Bull Hosp Jt Dis. 2000;59(1):40-6.
PubMed 10789037Mann S, Schutze M, Sola S, Piek J. Nonspecific pyogenic spondylodiscitis: clinical manifestations, surgical treatment, and outcome in 24 patients. Neurosurg Focus. 2004 Dec 15;17(6):E3. doi: 10.3171/foc.2004.17.6.3.
PubMed 15636573Sapico FL, Montgomerie JZ. Vertebral osteomyelitis. Infect Dis Clin North Am. 1990 Sep;4(3):539-50.
PubMed 2212605Martinez-Gutierrez O, Pena-Martinez V, Camacho-Ortiz A, Vilchez-Cavazos F, Simental-Mendia M, Tamez-Mata Y, Acosta-Olivo C. Spondylodiscitis treated with freeze-dried bone allograft alone or combined with autograft: A randomized and blinded trial. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211019101. doi: 10.1177/23094990211019101.
PubMed 34041968
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Infection Management With Structural Allograft
- ClinicalTrials.gov ID
- NCT03265561
- Acronym / sponsor ID
- OR15-005
- Conditions
- Bone Diseases, Infectious, Disease of Bone, Syndrome, Spine Infection, Allografts, Bone Graft; Complications, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Study start
- 14 May 2015 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
Background. Bone infections can involve the vertebral column, intervertebral disc space, spinal canal and soft tissues, can generate neurological deficit in addition to the destruction of the bone that causes functional disability. Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per 100,000 habitants. Management is bone debridement and bone reconstruction.
Objective. Demonstrate that the use of bone allograft is a functional method to stabilize the spine after a bone spinal infection Material and methods. Patients with vertebral bone destruction are included in two groups. Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus autograft. The bone reconstruction will be performed in a one-time surgical procedure. Bone consolidation, pain, functionality, and spine deformity will be evaluated.
Detailed description
Spinal bone infections can involve the bone vertebra, intervertebral disc space, spinal canal and soft tissues. It generate neurological deficit in addition to the destruction of the bone that causes functional disability and significant pain (Colmenero 1997). Spinal infections include discitis, osteomyelitis, epidural abscesses, meningitis, subdural empyema, and abscesses of the spinal cord (An, 2006). Only discitis and osteomyelitis can occur together (Skaf, 2010). Vertebral osteomyelitis is the most frequent, affecting 2 to 7 patients per 100,000 habitants (Bhavan, 2010; Grammatico 2003).
Pathogenic organisms reach the column by hematogenous pathway, arterial pathways (Batson's plexus) or by direct inoculation, due to a diagnostic or therapeutic intervention (Skaf, 2010). The natural history of pyogenic vertebral infections involves an infectious source or an incident followed by a period of intense pain, with or without generalized significant sepsis. Neurological deficit is caused by: [1] direct extension of the infection in the form of an abscess or bacterial communication with the spinal canal to the neural elements or [2] secondary compression of a pathological fracture as a result of bone softening. (Campbell´s, 2013).
Early diagnosis and treatment are essential for optimal outcomes (Weisz, 2000). The treatment goals may include eradicating the infection, relieving pain, preserving or restoring neurologic function, improving nutrition, and maintaining spinal stability (Tay, 2002). The aim of this study is to demonstrate that the use of bone allograft is a functional method to stabilize the spine after a bone spinal infection.
METHODS This study was approved by our Institutional Ethics and Research Committee. Patients with vertebral bone destruction are randomized included in two groups. Inclusion criteria: patients older than 18 years, any gender, pyogenic spinal infection with bone destruction and kyphotic deformity, without previous treatment of any kind, and Informed Consent signature. Exclusion criteria: patients with immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity. Elimination criteria: failure to comply with follow-up time, patient's express request to leave the study. The bone reconstruction will be performed in a one-step surgical procedure. All participants will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed guided by computed tomography (CT scan) and/or by fluoroscopy. A culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. The investigators will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram, and patients with infections with gram positive and negative microorganisms only will be included. Bone consolidation, pain, functionality, and spinal deformity will be evaluated.
The investigators will perform evaluations at 8, 12, 16, 20 and 24 weeks, and a CT scan will be realized, to evaluated the bone consolidation, defined as the presence of continuous trabeculae between the bone graft and the vertebra, according to the next classification system. Type 1 definitive fusion; Type 2 uncertain fusion; Type 3 definitive pseudoarthrosis.
Statistical analysis. The results will be reported in contingency tables, frequencies, percentages, measures of central tendency and dispersion. Qualitative variables will be analyzed with the chi-square statistic and quantitative variables with t-test for independent samples with a significance level of 95% with their respective confidence intervals, or with non-parametric statistics if necessary. Using a formula for hypothesis testing and difference of two proportions or with the proportion of a reference value, with a value zα of 1.94 with a level of significance of 95% for a queue, and a value zβ of 1.20 with a power of 80 %, With a proportion for group 1 of 0.38 and for group 2 of 0.83 (Zdeblick, Ducker) a sample of 19 participants was obtained per group. Statistical analysis will be performed with IBM SPSS version 20 (SPSS, Inc., Armon, NY).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus spongy autograft.
| Arm | Type | Receives |
|---|---|---|
| Bone allograft group | Experimental | Device: Bone allograftThis participants will receive bone structural allograft management for vertebral reconstruction. All patients undergo surgical procedure to realize debridement of the lesion, and the application of allograft without autograft. |
| Bone auto and allograft group | Active comparator | Device: Bone auto and allograft groupThis participants will receive bone structural allograft plus spongy autograft management for vertebral reconstruction. All patients undergo surgical procedure. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pyogenic spinal infection with bone destruction and spinal deformity, without previous treatment of any kind and Informed Consent signature
Key exclusion criteria (1 listed)
- immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity
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 |
|---|---|---|
| Bone allograftAll patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone allograft only. | Device | Bone allograft group |
| Bone auto and allograft groupAll patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone autograft plus bone allograft | Device | Bone auto and allograft group |
Primary outcome
Bone consolidation
Time frame: Twelve months
Radiography or CT scan will demonstrate bone graft consolidation
3 secondary outcomes
Pain scale
Time frame: Three months
Oswestry Scale
Time frame: Three months
Degree of spinal deformity
Time frame: Three months
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 18 Nov 2019.
- Background: PubMed 9496149Colmenero JD, Jimenez-Mejias ME, Sanchez-Lora FJ, Reguera JM, Palomino-Nicas J, Martos F, Garcia de las Heras J, Pachon J. Pyogenic, tuberculous, and brucellar vertebral osteomyelitis: a descriptive and comparative study of 219 cases. Ann Rheum Dis. 1997 Dec;56(12):709-15. doi: 10.1136/ard.56.12.709.
- Background: PubMed 16523124An HS, Seldomridge JA. Spinal infections: diagnostic tests and imaging studies. Clin Orthop Relat Res. 2006 Mar;444:27-33. doi: 10.1097/01.blo.0000203452.36522.97.
- Background: PubMed 20701886Skaf GS, Domloj NT, Fehlings MG, Bouclaous CH, Sabbagh AS, Kanafani ZA, Kanj SS. Pyogenic spondylodiscitis: an overview. J Infect Public Health. 2010;3(1):5-16. doi: 10.1016/j.jiph.2010.01.001. Epub 2010 Feb 19.
- Background: PubMed 20529294Bhavan KP, Marschall J, Olsen MA, Fraser VJ, Wright NM, Warren DK. The epidemiology of hematogenous vertebral osteomyelitis: a cohort study in a tertiary care hospital. BMC Infect Dis. 2010 Jun 7;10:158. doi: 10.1186/1471-2334-10-158.
- Background: PubMed 17568478Grammatico L, Baron S, Rusch E, Lepage B, Surer N, Desenclos JC, Besnier JM. Epidemiology of vertebral osteomyelitis (VO) in France: analysis of hospital-discharge data 2002-2003. Epidemiol Infect. 2008 May;136(5):653-60. doi: 10.1017/S0950268807008850. Epub 2007 Jun 14.
- Background: PubMed 16260656Govender S. Spinal infections. J Bone Joint Surg Br. 2005 Nov;87(11):1454-8. doi: 10.1302/0301-620X.87B11.16294. No abstract available.
- Background: PubMed 11153548Reihsaus E, Waldbaur H, Seeling W. Spinal epidural abscess: a meta-analysis of 915 patients. Neurosurg Rev. 2000 Dec;23(4):175-204; discussion 205. doi: 10.1007/pl00011954.
- Background: PubMed 12041940Tay BK, Deckey J, Hu SS. Spinal infections. J Am Acad Orthop Surg. 2002 May-Jun;10(3):188-97. doi: 10.5435/00124635-200205000-00005.
- Background: PubMed 10789037Weisz RD, Errico TJ. Spinal infections. Diagnosis and treatment. Bull Hosp Jt Dis. 2000;59(1):40-6.
- Background: PubMed 15636573Mann S, Schutze M, Sola S, Piek J. Nonspecific pyogenic spondylodiscitis: clinical manifestations, surgical treatment, and outcome in 24 patients. Neurosurg Focus. 2004 Dec 15;17(6):E3. doi: 10.3171/foc.2004.17.6.3.
- Background: PubMed 2212605Sapico FL, Montgomerie JZ. Vertebral osteomyelitis. Infect Dis Clin North Am. 1990 Sep;4(3):539-50.
- Derived from this study: PubMed 34041968Martinez-Gutierrez O, Pena-Martinez V, Camacho-Ortiz A, Vilchez-Cavazos F, Simental-Mendia M, Tamez-Mata Y, Acosta-Olivo C. Spondylodiscitis treated with freeze-dried bone allograft alone or combined with autograft: A randomized and blinded trial. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211019101. doi: 10.1177/23094990211019101.
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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 Acosta-Olivo, PhD principal investigator
Universidad Autonoma de Nuevo Leon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone allograft and Bone auto and allograft group in people with Bone Diseases, Infectious and Disease of Bone, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 1 inclusion and 1 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 18 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 1 site in Mexico. 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?
Bone consolidation (time frame: Twelve 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 NCT03265561, which also lists 12 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 18 Nov 2019.