Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty

NCT ID: NCT07319546

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthristis Arthroplasties, Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Accelerated rehabilitation

Rehabilitaion after TKR with the accelerated and optimal loading concepts

Group Type EXPERIMENTAL

Accelerated exercise

Intervention Type BEHAVIORAL

Based on optimal and accelerated concepts

Conventional rehabilitation

Group Type ACTIVE_COMPARATOR

Routine exercise

Intervention Type BEHAVIORAL

Conventional program

Interventions

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Accelerated exercise

Based on optimal and accelerated concepts

Intervention Type BEHAVIORAL

Routine exercise

Conventional program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Komsak Sinsurin, Ph.D., DPT

Role: STUDY_CHAIR

Mahidol University

Liying Yang

Role: PRINCIPAL_INVESTIGATOR

West Yunnan University of Applied Sciences, Yunnan province

Locations

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Hospital

Dali, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liying Yang, PT, M.Sc.

Role: CONTACT

+86 18787638700

Facility Contacts

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Liying Yang, PT, M.Sc.

Role: primary

+86 18787638700

Other Identifiers

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MU-CIRB 2025/443.2908

Identifier Type: -

Identifier Source: org_study_id

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