Spinal Infection Management With Structural Allograft

NCT03265561 | Completed DMC

• 1 other identifier: OR15-005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bone Diseases, Infectious; Disease of Bone; Syndrome; Spine Infection; Allografts; Bone Graft; Complications, Fracture

Outcome Measures

Primary Outcomes (1)

• Bone consolidation

  Radiography or CT scan will demonstrate bone graft consolidation

  Twelve months

Secondary Outcomes (3)

• Pain scale

  Three months

• Oswestry Scale

  Three months

• Degree of spinal deformity

  Three months

Study Arms (2)

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.

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.

Device: Bone auto and allograft group

Interventions

Bone allograft DEVICE

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 allograft group

Bone auto and allograft group DEVICE

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

Bone auto and allograft group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pyogenic spinal infection with bone destruction and spinal deformity, without previous treatment of any kind and Informed Consent signature

You may not qualify if:

• immunodeficiency, psychiatric disorders, patients with severe malnutrition, morbid obesity

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

Universidad Autonoma de Nuevo Leon

Monterrey, Nuevo León, 66460, Mexico

Location

Related Publications (12)

• 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.

  PMID: 9496149 BACKGROUND

• An 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.

  PMID: 16523124 BACKGROUND

• Skaf 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.

  PMID: 20701886 BACKGROUND

• Bhavan 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.

  PMID: 20529294 BACKGROUND

• Grammatico 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.

  PMID: 17568478 BACKGROUND

• Govender S. Spinal infections. J Bone Joint Surg Br. 2005 Nov;87(11):1454-8. doi: 10.1302/0301-620X.87B11.16294. No abstract available.

  PMID: 16260656 BACKGROUND

• Reihsaus 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.

  PMID: 11153548 BACKGROUND

• Tay 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.

  PMID: 12041940 BACKGROUND

• Weisz RD, Errico TJ. Spinal infections. Diagnosis and treatment. Bull Hosp Jt Dis. 2000;59(1):40-6.

  PMID: 10789037 BACKGROUND

• Mann 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.

  PMID: 15636573 BACKGROUND

• Sapico FL, Montgomerie JZ. Vertebral osteomyelitis. Infect Dis Clin North Am. 1990 Sep;4(3):539-50.

  PMID: 2212605 BACKGROUND

• Martinez-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.

  PMID: 34041968 DERIVED

MeSH Terms

Conditions

Bone Diseases, Infectious; Bone Diseases; Syndrome; Fractures, Bone

Condition Hierarchy (Ancestors)

Infections; Musculoskeletal Diseases; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Carlos Acosta-Olivo, PhD

  Universidad Autonoma de Nuevo Leon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Model Details: Bone allograft group will receive bone structural allograft; Auto and allograft group will receive bone structural allograft plus spongy autograft.

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 29, 2017
• Study Start: May 14, 2015
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

ME (1)