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

Lumbar Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03364790
• Other study ID #: Lumbar and Knee
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 1, 2017
• Start date: January 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Shuai Xu
• Phone: (86)18811792718
• Email: 1204649202[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Spine

Intervention

Procedure:
• PLIF
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.
• TKA
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lumbar lordosis angle (LL)	Lumbar lordosis angle	6 months
Secondary	Lumbar spinal area	measured by CT(GE light speed QX/i)	6 months
Secondary	knee extension angle	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.	6 months