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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03359564
Other study ID # MED007
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 26, 2017
Last updated November 30, 2017
Start date January 1, 2018
Est. completion date December 31, 2021

Study information

Verified date November 2017
Source Peking University People's Hospital
Contact YU Guanjie, bachelor
Phone 18500234005
Email yuguanjieok@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.


Description:

Evaluate the outcome of micro endoscopic discectomy (MED) by tubular retractors on safety and efficacy of the technique.Patients who underwent surgery for herniated disc using the tubular retractors. The results were evaluated by using VAS (Visual Analog Scale 0-5) for back and leg pain and ODI (Oswestry Disability Index). Patients were followed up at intervals of 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years after surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with at least 6 weeks of conservative treatment with positive nerve root tension signs, radicular pain

- Patients are diagnosed with lumbar disc herniation by MRI

- Patients who underwent surgery for herniated disc using the tubular retractor

Exclusion Criteria:

- Patients with large central disc herniation, chronic discogenic pain, discitis, multi-level disease, presence of instability or history of lumbar surgery

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
micro endoscopic discectomy
the patients receive micro endoscopic discectomy surgery therapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry Disability Index The efficacy of surgery were evaluated by using Oswestry Disability Index. 2 years after operation
Secondary Oswestry Disability Index The efficacy of surgery were evaluated by using Oswestry Disability Index. preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months after operation
Secondary Visual Analog Scale The efficacy of surgery were evaluated by using Visual Analog Scale for back and leg pain. preoperative evaluation and 1 week, 6 weeks, 3 months, 6 months, 12 months and 2 years postoperative follow-up
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