The Hierarchical Rehabilitation After Total Knee Arthroplasty

NCT05404568 | Unknown

• 1 other identifier: M2022120
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis (KOA) is one of the diseases that seriously affect the quality of human life, resulting in a significant disease burden. Total knee arthroplasty (TKA) is one of the ultimate treatments for knee osteoarthritis. Functional recovery after total knee arthroplasty depends on rehabilitation. With the incidence rate of knee osteoarthritis increasing, the amount of knee replacement surgery is increasing rapidly, the demand for medical resources and medical expenditure has increased. At present, there are many rehabilitation pathways after total knee arthroplasty, but there is no unified evidence-based medicine guide to guide postoperative rehabilitation. The current early rehabilitation pathways after total knee arthroplasty in China can be generally divided into three categories: inpatient rehabilitation, outpatient rehabilitation and home-based self-rehabilitation. The intensity and expenditure of rehabilitation treatment decrease in turn. Individual differences among patients lead to different rehabilitation treatment needs for functional recovery. How to predict the rehabilitation needs of patients after total knee arthroplasty and choose an appropriate rehabilitation pathway based on themselves need to be solved. We expected to establish a prediction model that we will be able to inform patients with knee osteoarthritis who just taken total knee arthroplasty and want to choose a pathway to rehabilitation by using the baseline status, that will help them to choose their best pathway to rehabilitation -- provide rehabilitation according to needs, save costs and improve the quality of life.

Conditions

Rehabilitation；Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (2)

• Satisfaction of patients of total knee arthroplasty

  Satisfaction of patients（1-10 scoring）

  12 months after Total Knee Arthroplasty

• HSS-KS score

  Hospital For Special Surgery Knee Score

  12 months after Total Knee Arthroplasty

Secondary Outcomes (7)

• Visual analog scale of patients

  3 weeks，3 and 12 months after Total Knee Arthroplasty

• Range of motion

  3 weeks，3 and 12 months after Total Knee Arthroplasty

• 10mWT

  3 weeks，3 and 12 months after Total Knee Arthroplasty

• WOMAC

  3 weeks，3 and 12 months after Total Knee Arthroplasty

• SF-36

  3 weeks，3 and 12 months after Total Knee Arthroplasty

Interventions

Total knee arthroplasty PROCEDURE

We included patients with knee osteoarthritis who planned to take total knee arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with knee osteoarthritis who will take total knee arthroplasty

You may qualify if:

• ① Knee osteoarthritis was diagnosed and total knee arthroplasty was planned;
• ② Good cognitive function, can cooperate and understand the contents of this test, and is willing to cooperate with rehabilitation evaluation and postoperative follow-up during perioperative period;
• ③ Aged 18 and above, voluntarily participated in the study and signed informed consent.

You may not qualify if:

• ① Accompanied by other local or systemic diseases that seriously affect the function of lower limbs, such as severe lumbar spinal stenosis, severe rheumatoid arthritis, etc;
• ② Patients have consciousness disorders, cognitive disorders, serious mental disorders and other diseases that affect limb function and cognition.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)