NCT02385695

Brief Summary

The purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

6.4 years

First QC Date

February 26, 2015

Last Update Submit

September 24, 2015

Conditions

Lumbar Spine Disc Degeneration

Keywords

Disc Degeneration DiseaseDDDmultilevel lumbar Disc Degeneration Disease

Outcome Measures

Primary Outcomes (1)

  • Range of Motion in Lumbar Spine

    24 Months

Secondary Outcomes (1)

  • Change in Oswestry Disability Index

    24 Months

Other Outcomes (4)

  • Numeric Rating Scale for Back Pain

    24 Months

  • Numeric Rating Scale for Leg Pain

    24 Months

  • Range of Motion in Sagittal Plane at Each Operated Level

    24 Months

  • +1 more other outcomes

Study Arms (2)

Posterior Dynamic Stabilization

Surgical treatment with posterior dynamic stabilization

Procedure: Posterior Dynamic Stabilization

Internal Fixation and Fusion

Surgical treatment with internal fixation and fusion

Procedure: Internal Fixation and Fusion

Interventions

Posterior Dynamic StabilizationPROCEDURE
Posterior Dynamic Stabilization
Internal Fixation and FusionPROCEDURE
Internal Fixation and Fusion

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of The Third Medical University/Southwest Hospital with multilevel lumbar degenerative disk disease.

You may qualify if:

  • Signed informed consent
  • Age between 30 and 75 years inclusive
  • Radiographic evidence of multi-level lumbar disc degeneration disease
  • Scheduled for 2- or 3-level lumbar discectomy at levels from L1 to S1 with or without dynamic stabilization or fusion
  • Preoperative ODI ≥ 30%
  • Clinical symptoms consistent with diagnosis of lumbar DDD:
  • Radicular back or lower extremity pain and/or
  • Decreased muscular strength and/or
  • Abnormal sensation
  • Failed to gain adequate symptom relief from at least one month of adequate non-operative treatment

You may not qualify if:

  • Cauda equina syndrome
  • Patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
  • Osteoporosis defined as T-score ≤ -3.5. BMD will be measured by DEXA performed on lumbar spine
  • Systemic infection such as AIDS and active hepatitis
  • Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation
  • Participation in a clinical trial of investigational drug or device within the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Military Medical University/Southwest Hospital

Chongqing, China

RECRUITING

MeSH Terms

Interventions

Fracture Fixation, InternalGene Fusion

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, OperativeRecombination, GeneticGenetic Phenomena

Study Officials

  • Qiang Zhou, MD, PhD

    Third Military Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Zhou, MD, PhD

CONTACT

86-13677669899zq_tlh@163.com

Branko Kopjar, MD, PhD

CONTACT

1-206-607-6861branko.kopjar@nor-consult.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Chair of the Department of Orthopedics, Chair of the Department of Spine Surgical Group

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 11, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

CN(1)