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Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly

Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03364790
Enrollment
120
Registered
2017-12-07
Start date
2018-01-01
Completion date
2020-12-30
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Osteoarthritis

Keywords

knee - spine syndrome, PLIF, TKA, sagittal parameters, neuroelectrophysiology

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.

Detailed description

A prosepective, single-center, factorial design, randomized study will be performed. In this study, the 120 participants with degenerative lumbar and knees disease coped with the standard were included, then were assigned into 4 groups randomly. The patients in 3 operation groups were treated with posterior lumbar interbody fusion(PLIF or PLF) or total knee arthroplasty (TKA) or both of them in one stage respectively and the forth group with no surgery. The comparison between observation and operation group and the difference on self-control pre-and post-operatively in operation group within 6 months were measured and valuated. The result will be formed by the correlation and causal relationship on sagittal parameters on photograph, biomechanics, neuroelectrophysiology and molecular biology and the conclusions drawn by the use of modern medical basic research methods will formulate the treatment principles on it.

Interventions

PROCEDURETKA

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.

PROCEDUREPLIF

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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed LSS need to be underwent PLIF or PLF 2. and Patients who need surgery and are limited by knee extension greater than 10 ° 3. ineffective conservative treatment for 6 months 4. patients have never relevant surgery before 5. Participants will be volunteered randomly assigned to surgery group and observation group.

Exclusion criteria

1. People have had similar lumbar or knee surgery 2. patients with lumbar or knee joint tumor or congenital malformation 3. there are contraindications of surgery such as infections and serious illness.

Design outcomes

Primary

MeasureTime frameDescription
Body angle6 monthsBody angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.

Secondary

MeasureTime frameDescription
Lumbar lordosis angle (LL)6 monthsLumbar lordosis angle
Lumbar spinal area6 monthsmeasured by CT(GE light speed QX/i)
knee extension angle6 monthsThe angle of knee extension the angle between the line connecting the greater trochanter of the femur and the lateral condyle of the femur and the line connecting the lateral condyle of the knee and the lateral condyle of the ankle.

Contacts

Primary ContactShuai Xu
1204649202@qq.com(86)18811792718

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026