NCT03364790

Brief Summary

The study has before mentioned the concept of "knee - spine syndrome" domestically, on the basement of which, the new study intends to perform another further study on the relationship between lumbar and lower extremity degenerative diseases.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

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

November 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

December 7, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

November 25, 2017

Last Update Submit

December 1, 2017

Conditions

Lumbar Osteoarthritis

Keywords

knee - spine syndromePLIFTKAsagittal parametersneuroelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Body angle

    Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.

    6 months

Secondary Outcomes (3)

  • Lumbar lordosis angle (LL)

    6 months

  • Lumbar spinal area

    6 months

  • knee extension angle

    6 months

Study Arms (4)

group1

EXPERIMENTAL

participant with posterior lumbar interbody fusion(PLIF or PLF)

Procedure: PLIF

group2

EXPERIMENTAL

participant with total knee arthroplasty (TKA)

Procedure: TKA

group3

EXPERIMENTAL

participant with PLIF and TKA on one stage

Procedure: PLIFProcedure: TKA

group4

NO INTERVENTION

participant without operation

Interventions

PLIFPROCEDURE

Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.

group1group3
TKAPROCEDURE

Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.

group2group3

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed LSS need to be underwent PLIF or PLF
  • and Patients who need surgery and are limited by knee extension greater than 10 °
  • ineffective conservative treatment for 6 months
  • patients have never relevant surgery before
  • Participants will be volunteered randomly assigned to surgery group and observation group.

You may not qualify if:

  • People have had similar lumbar or knee surgery
  • patients with lumbar or knee joint tumor or congenital malformation
  • there are contraindications of surgery such as infections and serious illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lin SI, Lin RM. Sensorimotor and balance function in older adults with lumbar nerve root compression. Clin Orthop Relat Res. 2002 Jan;(394):146-53. doi: 10.1097/00003086-200201000-00017.

    PMID: 11795726BACKGROUND

  • Matsuyama Y, Hasegawa Y, Yoshihara H, Tsuji T, Sakai Y, Nakamura H, Kawakami N, Kanemura T, Yukawa Y, Ishiguro N. Hip-spine syndrome: total sagittal alignment of the spine and clinical symptoms in patients with bilateral congenital hip dislocation. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2432-7. doi: 10.1097/01.brs.0000143671.67779.14.

    PMID: 15507807BACKGROUND

  • Murata Y, Takahashi K, Yamagata M, Hanaoka E, Moriya H. The knee-spine syndrome. Association between lumbar lordosis and extension of the knee. J Bone Joint Surg Br. 2003 Jan;85(1):95-9. doi: 10.1302/0301-620x.85b1.13389.

    PMID: 12585585BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Spine

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesOsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Study Officials

  • Haiying Liu

    Department of spinal surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuai Xu

CONTACT

(86)188117927181204649202@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of spinal surgery

Study Record Dates

First Submitted

November 25, 2017

First Posted

December 7, 2017

Study Start

January 1, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

December 7, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share