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NCT03591692
A Multi-center Study：Comparison of ACAF and ACCF in the Treatment of Cervical OPLL
NA trial testing ACAF surgery in Ossification of Posterior Longitudinal Ligament in 840 participants. Status unknown.
1 January 2020
Quick facts
| Lead sponsor | Shanghai Changzheng Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 840 |
| Start date | 1 January 2018 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 January 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- ACAF surgery
- ACCF surgery
Conditions studied
- Ossification of Posterior Longitudinal Ligament — all drugs for Ossification of Posterior Longitudinal Ligament →
Sponsor
Shanghai Changzheng Hospital
Who can join
Adults 45 to 70, any sex, with Ossification of Posterior Longitudinal Ligament. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background:The ACAF technology has been in clinical trials for some time. More and more doctors are starting to pay attention to this technology. There are many hospitals in China that have developed this technology. In order to prove that this technology has a significant effect on the treatment of cervical ossification of the posterior longitudinal ligament, we compared the efficacy of traditional ACCF surgery, in order to make the conclusion more true, we decided to carry out multi-center research. Purpose: The aim of this study is to compare the effectiveness of clinical outcomes between ACAF surgery and Anterior cervical corpectomy decompression and fusion（ACCF）in patients with OPLL and CSS . A study hypothesis is that ACAF surgery outcomes will be equal even better and lower surgical complications which compared to ACCF surgery. Methods: This study is a multi-center randomized clinical trial with randomized, controlled, multicenter research design. The OPLL patients will be randomly assigned in one of the two treatment groups: ACAF surgery and ACCF surgery. Five outcome measures will be collected pre-operative for baseline, and then at1, 12, 24, 48, 96,240weeks post-operative follow-up visits, including: (1)JOA) .(2)VAS. (3)NURIC Graded .(4)NDI . (5) radiological parameter. After randomization, the ACAF group will receive anterior controllable antedisplacement and fusion and the ACCF group will receive anterior cervical corpectomy decompression and fusion.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of ACAF surgery
Trials testing the same drug.
- NCT03312985 — Comparison of ACAF and ACCF in the Treatment of Cervical OPLL · NA · unknown
Other recruiting trials for Ossification of Posterior Longitudinal Ligament
Currently open trials in the same condition.
- NCT04968028 — Multi-centre Study to Evaluate ACAF Versus Laminoplasty in Treating Cervical Ossification of the Posterior Longitudinal · NA · recruiting
Other Shanghai Changzheng Hospital trials
Trials by the same sponsor.
- NCT07527884 — The Effect of Radiotherapy After Separation Surgery for Spinal Metastases · NA · not yet recruiting
- NCT07527728 — Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases · not yet recruiting
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- NCT07398326 — Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer · Phase 2 · recruiting
- NCT07381257 — Efficacy and Safety of Rifaximin-α in Treating MASLD · EARLY_PHASE1 · recruiting
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 NCT03591692 (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 Shanghai Changzheng Hospital
- Last refreshed: 19 July 2018
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/NCT03591692.
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