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NCT03312985: ACAF
Comparison of ACAF and ACCF in the Treatment of Cervical OPLL
NA trial testing ACAF surgery in Ossification of Posterior Longitudinal Ligament in 40 participants. Status unknown.
1 May 2021
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 | 40 |
| Start date | 1 May 2017 |
| Primary completion | 1 May 2021 |
| Estimated completion | 1 January 2022 |
| 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: Dr. Shi recently proposed a new technique as Ossification of anterior decompression surgery, which is also called anterior controllable antedisplacement and fusion (ACAF) , for ossification of the posterior longitudinal ligament (OPLL) and cervical canal stenosis（CSS）. Yet, the effectiveness and safety should be further studied. 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 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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- PubMed search for NCT03312985
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Related trials
Other trials of ACAF surgery
Trials testing the same drug.
- NCT03591692 — A Multi-center Study：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.
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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 NCT03312985 (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: 17 November 2017
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/NCT03312985.
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