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Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

Primary Purpose

Joint Diseases, Arthritis Knee, Arthroplasty Complications

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Total knee arthroplasty with a Mobile Bearing system.
Total knee arthroplasty with a Fixed Bearing system.
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Joint Diseases focused on measuring Mobile bearing, Fixed bearing, Knee Arthroplasty

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Damascus university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mobile Bearing Design TKA

Fixed Bearing Design TKA

Arm Description

Patients who were randomized to receive the PFC Sigma Mobile Bearing TKA system

Patients who were randomized to receive the PFC Sigma Fixed Bearing TKA system

Outcomes

Primary Outcome Measures

Anterior knee pain
Anterior knee pain will be assessed by the clinical anterior knee pain rating system described by Waters and Bentley (AKPS). The scale is composed of 13 items that evaluate subjective symptoms and functional limitations. The minimum score is 0 points and the maximum score is 100 points. An athlete with no sign of anterior knee pain would have a score of 100. All subjects with a positive AKPS (score less than 100) underwent a further assessment to determine patellofemoral pain diagnosis.

Secondary Outcome Measures

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.
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)
perioperative complications
such as infection, VET, etc

Full Information

First Posted
January 11, 2023
Last Updated
September 22, 2023
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT05696418
Brief Title
Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
September 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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. 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.
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 a group of patients who will undergo 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 two years 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Diseases, Arthritis Knee, Arthroplasty Complications
Keywords
Mobile bearing, Fixed bearing, Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile Bearing Design TKA
Arm Type
Experimental
Arm Description
Patients who were randomized to receive the PFC Sigma Mobile Bearing TKA system
Arm Title
Fixed Bearing Design TKA
Arm Type
Experimental
Arm Description
Patients who were randomized to receive the PFC Sigma Fixed Bearing TKA system
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty with a Mobile Bearing system.
Intervention Description
The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Mobile Bearing system without resurfacing the patella.
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty with a Fixed Bearing system.
Intervention Description
The prostheses will be cruciate scarifying cemented DePuy Synthes PFC Sigma with a Fixed Bearing system without resurfacing the patella.
Primary Outcome Measure Information:
Title
Anterior knee pain
Description
Anterior knee pain will be assessed by the clinical anterior knee pain rating system described by Waters and Bentley (AKPS). The scale is composed of 13 items that evaluate subjective symptoms and functional limitations. The minimum score is 0 points and the maximum score is 100 points. An athlete with no sign of anterior knee pain would have a score of 100. All subjects with a positive AKPS (score less than 100) underwent a further assessment to determine patellofemoral pain diagnosis.
Time Frame
1-2 years after surgery
Secondary Outcome Measure Information:
Title
Knee Society Score (KSS)
Description
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.
Time Frame
1-2 years after surgery
Title
Forgotten Joint Scale (FJS)
Description
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)
Time Frame
1-2 years after surgery
Title
perioperative complications
Description
such as infection, VET, etc
Time Frame
assessed within two weeks intervals until 6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaber Ibrahim, M.D, Ph.D
Organizational Affiliation
Damascus University
Official's Role
Study Director
Facility Information:
Facility Name
Damascus university
City
Damascus
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
14646769
Citation
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.
Results Reference
background
PubMed Identifier
11716371
Citation
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.
Results Reference
background
PubMed Identifier
17621230
Citation
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.
Results Reference
background
PubMed Identifier
19092005
Citation
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.
Results Reference
background
PubMed Identifier
23206460
Citation
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.
Results Reference
background
PubMed Identifier
24453622
Citation
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.
Results Reference
background
PubMed Identifier
12571296
Citation
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.
Results Reference
background
PubMed Identifier
22000572
Citation
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.
Results Reference
background

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Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

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