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

Not Applicable

• Conditions: Lumbar Osteoarthritis
• Interventions: Procedure: PLIF; Procedure: TKA

• Registration Number: NCT03364790
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Study First Submitted: 2017-11-25
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-01
• Last Update Submitted: 2017-12-01
• Study First Posted: 2017-12-07
• Last Update Posted: 2017-12-07
• Study Start: 2018-01-01
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
group3	PLIF	participant with PLIF and TKA on one stage
group2	TKA	participant with total knee arthroplasty (TKA)
group3	TKA	participant with PLIF and TKA on one stage
group1	PLIF	participant with posterior lumbar interbody fusion(PLIF or PLF)

Primary Outcome Measures

Name	Time	Method
Body angle	6 months	Body angle is defined an angle of the shoulder and femoral trochanter connection and the greater trochanter and knee lateral condyle connection.

Secondary Outcome Measures

Name	Time	Method
Lumbar spinal area	6 months	measured by CT(GE light speed QX/i)
Lumbar lordosis angle (LL)	6 months	Lumbar lordosis angle
knee extension angle	6 months	The 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.