Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon

Intervertebral Disc Degeneration Clinical Trial

Official title:

Prospective Study of Risk Factors and Outcomes Following Total Knee Arthroplasty and Spinal Surgeon

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01989481
• Other study ID #: 2012BAI10B02-OS
• Status: Recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: March 23, 2015
• Start date: November 2013

Study information

• Verified date: March 2015
• Source: Beijing Jishuitan Hospital
• Contact: Chengai Wu, Doctor
• Phone: +86-010-58516611
• Email: wuchengai05[@]163.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial Summary

The purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. The patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease.

2. Must be between 18 and 65 years of age, of either sex.

3. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria:

1. Patients with Mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee.

2. The patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Osteoarthritis;

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Jishuitan Hospital	Beijing Hospital, Chinese PLA General Hospital, Peking Union Medical College Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of functional score over time in the patients after operation		3, 6, 12 months after surgery	Yes
Secondary	Change of quality of life score over time in the patients after operation		3, 6, 12 monthes after surgery	Yes