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NCT Number: NCT05696418

Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

Osteoarthritis is the most common cause of chronic joint disease, and its incidence has increased due to the high average life expectancy, in addition to the high incidence of obesity. Total knee arthroplasty is currently an accepted treatment for severe degenerative conditions and there are various implant systems with special features depending on component geometry, degree of fit of the articular surfaces, and fixation techniques. A tibial component with mobile polyethylene has been developed as an alternative to fixed polyethylene because it has theoretical advantages in terms of increasing the range of motion, reducing wear conditions, and reducing the incidence of anterior knee pain when the articular surface of the patella is not resurfaced.

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Key information

Conditions

Joint Diseases Arthritis Knee Arthroplasty Complications Musculoskeletal Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus university

Damascus, Syria

About this study

The study is a randomized controlled clinical trial where the sample will be collected within one year from the date of approval of the Scientific Research Council at Damascus University. The sample consists of patients undergoing a total primary knee arthroplasty without patellar resurfacing following primary arthritis knee. The patients will be randomly divided into two groups. The first will be a primary total knee arthroplasty with a mobile bearing, and the second group with a fixed bearing. Then the patients will be followed for at least one year.

The data of the patients included in the study will be collected before the surgical operation, then the surgery; followed up for at least one year after it, and then compared between the two groups in terms of a range of motion and functional and clinical results according to the Knee Society Score (KSS) and the anterior knee pain scale, and patient satisfaction assessment according to the Forgotten Joint Scale (FJS).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients with expected primary total knee arthroplasty

Exclusion criteria

  • Mediolateral instability
  • Infective arthritis
  • Severe deformity
  • Revision
  • Patients with severe obesity according to the Body Mass Index (BMI < 35).

Treatment and study plan

Total knee arthroplasty with a Mobile Bearing system.

Procedure

The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Mobile Bearing system without resurfacing the patella.

Total knee arthroplasty with a Fixed Bearing system.

Procedure

The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Fixed Bearing system without resurfacing the patella.

Primary outcomes

  1. Anterior knee pain

    Time frame: 1-2 years after surgery

    Anterior knee pain will be assessed by questionnaire.

Secondary outcomes

  1. Knee Society Score (KSS)

    Time frame: 1-2 years after surgery

    Clinical and functional outcomes will be assessed by Knee Society Score (KSS). The knee society score (KSS) contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). When calculating the score, deductions are taken for assistive devices and flexion contractures, misalignment, or extension lag. The Knee Society Score is divided into three sessions: it consists of the Knee Score (100 points), the Knee Function (100 points), and the patient classification system. The classification system separates the patients into three categories depending on their medical conditions - A: unilateral or bilateral (contralateral knee operated successfully); B: unilateral -contralateral knee symptomatic; C: multiple arthritis. The two scores are initially marked at zero and points are assigned or deducted according to specific criteria.

  2. Forgotten Joint Scale (FJS)

    Time frame: 1-2 years after surgery

    Patient satisfaction will be assessed by Forgotten Joint Scale (FJS). The FJS-12 consists of twelve equally-weighted questions that are each answered on a five-level Likert scale aimed to measure patient satisfaction. The questionnaire was developed with the consideration that joint awareness is a very important and highly discriminative outcome parameter, especially in patients with good-to-excellent joint function. Answers to each question are individually scored and summed to create a raw composite score that is normalized to range from 0 (worst condition) to 100 points (best condition)

  3. perioperative complications

    Time frame: assessed within two weeks intervals until 6 months after surgery

    such as infection, VET, etc

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Effect of Using Mobile Bearing on the Incidence Rate of Anterior Knee Pain in Primary Total Knee Arthroplasty Without Patellar Resurfacing (A Randomized Controlled Clinical Trial)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Jul 16, 2024

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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