Health TrialsbyHealthPanel

OssiMend BA in Posterolateral Instrumented Lumbar Fusion

ConditionsSpinal DiseaseDegenerative Disc Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCollagen Matrix

About this trial

The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Instability as defined by >3mm translation or >5 degrees angulation

Osteophyte formation of facet joints or vertebral endplates

Decreased disc height, on average by >2mm, but dependent upon the spinal level

Herniated nucleus pulposus

Disqualifiers

Subject is under 18 years of age at the time of consent

Subject has had prior lumbar spine fusion surgery at any level

Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy

Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis

Trial population

Subjects must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • OssiMend™ Bioactive Moldable

    Device

    Lumbar Spine fusion with OssiMend™ Bioactive Moldable

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: OssiMend™ Bioactive Moldable1 intervention

Trial outcomes

Primary outcomes

1

Fusion Success

Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success

Time frame
12 months

Secondary outcomes

1

Visual analog scale (VAS) of back and leg (left and right)

Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)

Time frame
12 months
2

Oswestry Lower Back Pain Questionnaire

Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire

Time frame
12 months
3

SF36

Pain and function as measured by the Short - Form 36

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Collagen Matrix

Lead sponsor

Source ClinicalTrials.gov
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