Clinical trial NCT03364790: Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly
Official title: Correlation Between the Lower Extremities and Lumbar Degenerative Diseases of the Elderly and Formulation on Treatment Principles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Osteoarthritis
Keywords: knee - spine syndrome
PLIF
TKA
sagittal parameters
neuroelectrophysiology
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-07
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body angle
timeFrame: 6 months
Secondary outcomes:
measure: Lumbar lordosis angle (LL)
timeFrame: 6 months
measure: Lumbar spinal area
timeFrame: 6 months
measure: knee extension angle
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of spinal surgery
name: Haiying Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1097/01.brs.0000143671.67779.14.
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. doi: 10.1302/0301-620x.85b1.13389.