SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00869882
• Date of registration: 25/03/2009
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Bordeaux
• Public title: SPONGIT: Comparison of Two Surgical Approaches in the Treatment of Degenerative Spondylolysthesis SPONGIT
• Scientific title: Comparison of 2 Surgical Approaches in the Treatment of Degenerative Spondylolysthesis: Posterolateral Fusion With Instrumentation (GPLI) Plus or Minus Transforaminal Lumbar Interbody Fusion (TLIF)
• Date of first enrolment: June 2009
• Target sample size: 60
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00869882
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Antoine BENARD, MD
• Affiliation: University Hospital Bordeaux, France

• Name: Patrick GUERIN, MD
• Affiliation: University Hospital Bordeaux, France

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults aged less than 75,

- Having been informed about clinical trial objectives and risk,

- Covered by health insurance system,

- Suffering from degenerative spondylolisthesis (whatever the grade and intervertebral
disc height) needing one-level surgical fusion due to either invalidating
lombalgia/radiculalgia despite 6-month optimal medical treatment and/or motor
neurological symptoms.

Exclusion Criteria:

- Previous lumbar fusion,

- Previous spine traumatism,

- Presence of at least one major contraindication to surgery and/or general anaesthesia
(ie, non controlled coagulopathy, active infection, or serious underlying disease,
auto-immune affection).

- Presence of at least one contraindication to either TLIF or GPLI,

- Severe radiological osteoporosis.

- Active cancer at time of inclusion into the study.

- Unlikely to comply with the requirements of the study and/or to complete the study
for psychological, social, familial or geographical reasons.

- Under any administrative or legal supervision.



Age minimum: 18 Years
Age maximum: 74 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Degenerative Spondylolisthesis

Intervention(s)

Procedure: Posterolateral fusion with instrumentation

Procedure: Circumferential arthrodesis

Primary Outcome(s)

Success rate defined as fusion associated to at least a 3-degree increase of segmental lordosis angle and the absence of a reintervention due to a failure of the initial intervention [Time Frame: 24 months after surgery]

Secondary Outcome(s)

Quality of life outcome: SF-36 [Time Frame: 2, 6, 12 and 24 months after surgery]

Functional outcome: Oswestry Disability Index and modified Prolo Economic and Functional scores [Time Frame: 2, 6, 12 and 24 months after surgery]

Major complication (ie, life threatening haemorrhage, severe and persisting neurological worsening, deep infection) rate, and minor complication rate [Time Frame: within 24 months after surgery]

Per and post operative surgery parameters (ie, operative time, blood loss, hospitalization stay duration) [Time Frame: within hospital stay due to surgery]

Change of pelvic and radiological parameters (ie, lumbar lordosis angle, medial intervertebral space height [Time Frame: 2, 6, 12 and 24 months after surgery]

Lumbar and radicular pain outcome [Time Frame: 2, 6, 12 and 24 months after surgery]

Success rate defined as both fusion and at least 3-degree increase of segmental lordosis angle [Time Frame: 6 and 12 months after surgery]

Secondary ID(s)

CHUBX 2008/33

Source(s) of Monetary Support

Please refer to primary and secondary sponsors