Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion

NCT04781517 | Unknown DMC

• 1 other identifier: LDDAFQ-PRO
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness, and there is no scale for evaluating lumbar stiffness in China.Based on the Delphi method and the analytic hierarchy process, this study will improve and optimize the quality of life evaluation system for patients with severe degenerative lumbar disease, so as to obtain a concise, practical, and effective patient-reported outcome instrument.

Conditions

Lumbar Spine Degeneration

Keywords

lumbar spine; questionnaire; patient reported outcome measures; quality of life; lumbar fusion

Outcome Measures

Primary Outcomes (9)

• The Oswestry Disability Index (ODI)

  Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.

  In 7 days before lumbar fusion

• The Japanese Orthopedic Association score(JOA-29)

  Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.

  In 7 days before lumbar fusion

• The novel PRO instrument

  Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.

  In 7 days before lumbar fusion

• The Oswestry Disability Index (ODI)

  Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.

  6 months after lumbar fusion

• The Japanese Orthopedic Association score(JOA-29)

  Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.

  6 months after lumbar fusion

• The novel PRO instrument

  Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.

  6 months after lumbar fusion

• The Oswestry Disability Index (ODI)

  Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.

  12 months after lumbar fusion

• The Japanese Orthopedic Association score(JOA-29)

  Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.

  12 months after lumbar fusion

• The novel PRO instrument

  Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.

  12 months after lumbar fusion

Study Arms (2)

Short-segment group

Lumbar degenerative diseases' patients,whose lumbar fixed segments less than 3 was divided into Short-segment group(200).

Long-segment group

Lumbar degenerative diseases' patients,whose lumbar fixed segments no less than 3 was divided into Long-segment group(200).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with lumbar degenerative diseases,planning or undergone their first lumbar fusion,are willing to participate in this research.They have no neurological diseases, severe cervical/thoracic spine disease or other diseases which seriously affect their quality of life, and haven't suffered lumbar trauma after lumbar fusion.

You may qualify if:

• Clinical diagnosis of Lumbar Spine Degeneration
• Plan for or have undergone lumbar fusion
• Be willing to participate in this research

You may not qualify if:

• Combined with neurological disease such as Motor neuron disease, Progressive muscular dystrophy, Peripheral neuropathy, Spinal cord disease, et al.
• Combined with severe cervical/thoracic spine disease or other diseases that seriously affect the quality of life
• Suffer lumbar spine trauma after lumbar fusion
• Preoperative cases exclude patients who plan for revision surgery
• Be unwilling to participate in this research

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Study Officials

• Weishi Li, PhD

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Weishi Li, PhD

CONTACT

15611908864; wslee@163.com

Yu Jiang, PhD

CONTACT

18501125711; jiangyu@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: March 4, 2021
• Study Start: May 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 9, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)