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Joint DiseasesNCT05696418

Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

A study testing Total knee arthroplasty with a Mobile Bearing system. and Total knee arthroplasty with a Fixed Bearing system. in people with Joint Diseases and Arthritis Knee, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
What is being tested?
Total knee arthroplasty with a Mobile Bearing system. and Total knee arthroplasty with a Fixed Bearing system.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSyria
Study dates
15 Jan 2021to 25 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with expected primary total knee arthroplasty

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Damascus university

    Damascus

Other trials in Syria

About this study

Official 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)

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.

Read the detailed description

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).

Being tested
Total knee arthroplasty with a Mobile Bearing system., Total knee arthroplasty with a Fixed Bearing system.
Keywords
Mobile bearing, Fixed bearing, Knee Arthroplasty
Medical subject headings
Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total knee arthroplasty with a Mobile Bearing system.Procedure or surgery

    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 or surgery

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

Study groups in NCT05696418
Study groupRoleWhat they receive
Mobile Bearing Design TKAExperimentalPatients who were randomized to receive the PFC Sigma Mobile Bearing TKA system
Receives: Procedure: Total knee arthroplasty with a Mobile Bearing system.
Fixed Bearing Design TKAExperimentalPatients who were randomized to receive the PFC Sigma Fixed Bearing TKA system
Receives: Procedure: Total knee arthroplasty with a Fixed Bearing system.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anterior knee pain

    Anterior knee pain will be assessed by questionnaire.

    Measured: 1-2 years after surgery

Secondary outcomes (3)

  1. Knee Society Score (KSS)

    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.

    Measured: 1-2 years after surgery

  2. Forgotten Joint Scale (FJS)

    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)

    Measured: 1-2 years after surgery

  3. perioperative complications

    such as infection, VET, etc

    Measured: assessed within two weeks intervals until 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start15 Jan 2021
  3. Primary completion15 Mar 2024
  4. Study completion25 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05696418
Sponsor's protocol ID
UDMS-Orthopedics-2-2023
Status last verified
Jul 2024
First submitted
11 Jan 2023
Last updated
16 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang CH, Ma HM, Lee YM, Ho FY. Long-term results of low contact stress mobile-bearing total knee replacements. Clin Orthop Relat Res. 2003 Nov;(416):265-70. doi: 10.1097/01.blo.0000093890.12372.46.

    PubMed 14646769

  • Kim YH, Kook HK, Kim JS. Comparison of fixed-bearing and mobile-bearing total knee arthroplasties. Clin Orthop Relat Res. 2001 Nov;(392):101-15. doi: 10.1097/00003086-200111000-00013.

    PubMed 11716371

  • Dennis DA, Komistek RD, Scuderi GR, Zingde S. Factors affecting flexion after total knee arthroplasty. Clin Orthop Relat Res. 2007 Nov;464:53-60. doi: 10.1097/BLO.0b013e31812f785d.

    PubMed 17621230

  • Hooper G, Rothwell A, Frampton C. The low contact stress mobile-bearing total knee replacement: a prospective study with a minimum follow-up of ten years. J Bone Joint Surg Br. 2009 Jan;91(1):58-63. doi: 10.1302/0301-620X.91B1.20484.

    PubMed 19092005

  • Li B, Bai L, Fu Y, Wang G, He M, Wang J. Comparison of clinical outcomes between patellar resurfacing and nonresurfacing in total knee arthroplasty: retrospective study of 130 cases. J Int Med Res. 2012;40(5):1794-803. doi: 10.1177/030006051204000517.

    PubMed 23206460

  • Khan A, Pradhan N. Results of total knee replacement with/without resurfacing of the patella. Acta Ortop Bras. 2012;20(5):300-2. doi: 10.1590/S1413-78522012000500011.

    PubMed 24453622

  • Waters TS, Bentley G. Patellar resurfacing in total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):212-7. doi: 10.2106/00004623-200302000-00005.

    PubMed 12571296

  • Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.

    PubMed 22000572

Questions about this trial

What is this clinical trial studying?

A study testing Total knee arthroplasty with a Mobile Bearing system. and Total knee arthroplasty with a Fixed Bearing system. in people with Joint Diseases and Arthritis Knee, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anterior knee pain (time frame: 1-2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696418, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.

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