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NCT Number: NCT07319546

Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty

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.

Recruiting

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Accelerated exercise

Behavioral

Based on optimal and accelerated concepts

Routine exercise

Behavioral

Conventional program

Primary outcomes

  1. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: From enrollment to the end of 6-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Liying Yang, PT, M.Sc.

CONTACT

[email protected]

+86 18787638700

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effectiveness of Accelerated Rehabilitation on Knee Joint Function and Quality of Life in Individuals With Total Knee Arthroplasty: A Double Blind Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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