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NCT05536453
Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine
trial testing Lumbar Interbody Fusion Devices in Degenerative Disc Disease (DDD) in 465 participants. Completed in 16 July 2025.
16 July 2025
Quick facts
| Lead sponsor | Spine and Scoliosis Research Associates |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 465 |
| Start date | 16 August 2022 |
| Primary completion | 16 July 2025 |
| Estimated completion | 16 July 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Lumbar Interbody Fusion Devices
Conditions studied
- Degenerative Disc Disease (DDD) — all drugs for Degenerative Disc Disease (DDD) →
Sponsor
Spine and Scoliosis Research Associates
Who can join
Adults 18 to 110, any sex, with Degenerative Disc Disease (DDD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this retrospective study is an investigational clinical follow-up, of patients treated with interbody fusion devices (IBFD), both expandable (EXP) and static (STC), according to their intended use and cleared labeling to understand IBFD design and technique characteristics that affect occurrence rates of subsidence. Patients treated with IBFD's (both EXP and STC) according to their intended use and cleared labeling 1. EXP IBFD's that expand in width and height demonstrate reduced occurrence of subsidence post-operatively when compared to EXP IBFD's that expand in height only and STC IBFD's. 2. EXP IBFD's that are comprised of multi-material composition with Polyetheretherketone (PEEK) endplate contacting surfaces demonstrate reduced occurrence of subsidence on post-operative radiographs when compared to EXP and STC IBFD's that are primarily comprised of Ti with Ti endplate contacting surfaces. 3. achieve radiographic fusion at a rate consistent with the state-of-the-art 4. achieve significant improvements in pain and function compared to baseline 5. experience adverse events at a frequency comparable to reported rates for TLIF or PLIF surgery 6. not demonstrate any intraoperative complications during the implant process 7. operative approach does not correlate with increased rates of subsidence
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05536453
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Related trials
Other recruiting trials for Degenerative Disc Disease (DDD)
Currently open trials in the same condition.
- NCT03737461 — Efficacy of Intradiscal Injection of BM-MSC in Subjects With Chronic Low Back Pain (LBP) Due to Lumbar Degenerative Disc · Phase 2, PHASE3 · active not recruiting
Other Spine and Scoliosis Research Associates trials
Trials by the same sponsor.
- NCT04839783 — Single Position Spine Surgery Registry · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05536453 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Spine and Scoliosis Research Associates
- Last refreshed: 20 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05536453.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing