The Hierarchical Rehabilitation After Total Knee Arthroplasty

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05404568
Collaborator
(none)
300
1
4
74.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Total knee arthroplasty

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Hierarchical Rehabilitation After Total Knee Arthroplasty
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Satisfaction of patients of total knee arthroplasty [12 months after Total Knee Arthroplasty]

    Satisfaction of patients(1-10 scoring)

  2. HSS-KS score [12 months after Total Knee Arthroplasty]

    Hospital For Special Surgery Knee Score

Secondary Outcome Measures

  1. Visual analog scale of patients [3 weeks,3 and 12 months after Total Knee Arthroplasty]

    Visual analog scale of patients

  2. Range of motion [3 weeks,3 and 12 months after Total Knee Arthroplasty]

    Range of motion of undergoing surgery

  3. 10mWT [3 weeks,3 and 12 months after Total Knee Arthroplasty]

    10 meters working test

  4. WOMAC [3 weeks,3 and 12 months after Total Knee Arthroplasty]

    Western Ontario and McMaster Universities Osteoarthritis Index

  5. SF-36 [3 weeks,3 and 12 months after Total Knee Arthroplasty]

    36-Item Short Form Survey

  6. Satisfaction of patients of total knee arthroplasty [3 weeks,3 months after Total Knee Arthroplasty]

    Satisfaction of patients(1-10 scoring)

  7. HSS-KS score [3 weeks,3 months after Total Knee Arthroplasty]

    Hospital For Special Surgery Knee Score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Peking Beijing China 100089

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT05404568
Other Study ID Numbers:
  • M2022120
First Posted:
Jun 3, 2022
Last Update Posted:
Jun 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 3, 2022