Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty

NCT07319546 | Recruiting

• 1 other identifier: MU-CIRB 2025/443.2908
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.

Conditions

Knee Osteoarthristis; Arthroplasties, Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  From enrollment to the end of 6-month follow-up

Study Arms (2)

Accelerated rehabilitation

EXPERIMENTAL

Rehabilitaion after TKR with the accelerated and optimal loading concepts

Behavioral: Accelerated exercise

Conventional rehabilitation

ACTIVE COMPARATOR

Behavioral: Routine exercise

Interventions

Accelerated exercise BEHAVIORAL

Based on optimal and accelerated concepts

Accelerated rehabilitation

Routine exercise BEHAVIORAL

Conventional program

Conventional rehabilitation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with end-stage knee OA necessitating primary unilateral TKA.

You may not qualify if:

• History of joint infections, cancer, or inflammatory arthritis.
• End-stage OA from rheumatoid or septic arthritis.
• Individuals with neurological disorders such as Alzheimer's disease, - Parkinson's disease, stroke.
• Individuals who are unable to follow a structured rehabilitation protocol.
• Previous history of knee surgeries (other than arthroscopy).
• Severe comorbidities that would hinder participation (e.g., advanced cardiovascular diseases).
• Individuals who have severe osteoporosis.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Hospital

Dali, Yunnan, China

RECRUITING

Study Officials

• Komsak Sinsurin, Ph.D., DPT

  Mahidol University

  STUDY CHAIR

• Liying Yang

  West Yunnan University of Applied Sciences, Yunnan province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liying Yang, PT, M.Sc.

CONTACT

+86 18787638700; liying.yan@student.mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)