A Multi-Center Bidirectional Cohort Study on Total Knee Arthroplasty for the Treatment of Knee Osteoarthritis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

The purpose of this study is to evaluate the clinical benefits of different types of total knee arthroplasty (TKA) in osteoarthritis treatment. The study aims to compare surgical outcomes, functional recovery, complication rates, and cost-effectiveness among personalized, semi-personalized, and conventional TKA in a multi-center, bidirectional cohort study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 50-80 years.

Diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis requiring total knee arthroplasty.

Willing and able to provide informed consent.

Disqualifiers

History of prior knee surgery or knee replacement.

Severe knee deformity (valgus >20° or varus >15°) or instability.

Severe contracture (>25° flexion contracture).

Undergoing total knee revision surgery.

Trial population

The study population consists of 120 patients aged 50-80 years diagnosed with end-stage knee osteoarthritis, post-traumatic arthritis, avascular necrosis, or inflammatory arthritis, who require total knee arthroplasty (TKA). Participants will be recruited from multiple centers, including Beijing Tsinghua Chang Gung Hospital, Peking University Shougang Hospital, and Beijing Chaoyang Hospital. The study will compare personalized, semi-personalized, and conventional TKA procedures in terms of surgical outcomes, functional recovery, complication rates, and cost-effectiveness.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Cohort 1

Trial outcomes

Primary outcomes

1

Knee Society Score (KSS)

The KSS is a standardized assessment tool used to evaluate knee function and pain following total knee arthroplasty. It includes an objective knee score and a functional score, measuring alignment, stability, and range of motion.

Time frame
At baseline, 6 months, and 12 months post-surgery

Secondary outcomes

1

Pain Severity

Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess pain levels pre- and post-surgery.

Time frame
At baseline, 6 months, and 12 months post-surgery
2

Functional Improvement

Functional improvement will be measured using SF-36 Health Survey, Knee Injury and Osteoarthritis Outcome Score (KOOS), and gait analysis.

Time frame
At baseline, 6 months, and 12 months post-surgery.
3

Prosthesis Positioning and Alignment

Radiographic evaluation will assess implant positioning and limb alignment.

Time frame
At baseline and 12 months post-surgery.
4

Surgical Complication Rate

The rate of postoperative complications including infections, deep vein thrombosis (DVT), and revision surgeries will be recorded.

Time frame
At 12 months post-surgery.

Other outcomes

Sponsors and contacts

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Beijing Tsinghua Chang Gung Hospital

Lead sponsor

Peking University Shougang Hospital

Collaborator

Beijing Chao Yang Hospital

Collaborator

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