N/A Completed N=102 Treatment

Spineology Clinical Outcomes Trial: An IDE Investigation

lumbar degenerative disc disease

Source: ClinicalTrials.gov NCT02347410 ↗

Enrolled (actual)

102

Serious AEs

11.8%

Results posted

Oct 2021

Primary outcomePrimary: Overall Success — 71 Participants

Summary

This study evaluated the safety and effectiveness of the Spineology Interbody Fusion System (SIFS) in an instrumented interbody lumbar fusion in subjects presenting with symptomatic single-level lumbar degenerative disc disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Success	71	—

Eligibility Criteria

Inclusion Criteria

Skeletally mature;
Confirmed symptomatic single-level lumbar degenerative disc disease (DDD) between L2 and S1;
Minimum low back Visual Analog Scale (VAS) pain score of 40mm;
Minimum Oswestry Disability Index (ODI) score of 40;
Received at least 6-months of conservative care; and
Willing and able to comply with protocol evaluations and provide informed consent.

Exclusion Criteria

Previous fusion or total disc replacement at the index level;
Greater than Grade I spondylolisthesis;
Has symptomatic multi-level lumbar DDD;
Active systemic infection or infection at the local surgical site;
Active or suspected malignancy;
Body Mass Index of greater than or equal to 40;
Significant metabolic bone disease;
Taking medication known to interfere with bone healing;
Has a current substance abuse disorder;
Has a somatoform, dissociative, eating or psychotic disorder;
Waddell Signs of inorganic behavior;
Current tobacco user;
Is a prisoner;
If female, pregnant or contemplating pregnancy during follow-up period; or
Enrolled in a concurrent clinical investigation that may confound the findings of the current investigation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02347410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.