Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

NCT ID: NCT05696418

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2024-03-25

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 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).

Conditions

Joint Diseases; Arthritis Knee; Arthroplasty Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mobile Bearing Design TKA

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

Group Type: EXPERIMENTAL

Total knee arthroplasty with a Mobile Bearing system.

Intervention Type: PROCEDURE

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

Fixed Bearing Design TKA

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

Group Type: EXPERIMENTAL

Total knee arthroplasty with a Fixed Bearing system.

Intervention Type: PROCEDURE

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

Interventions

Total knee arthroplasty with a Mobile Bearing system.

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

Intervention Type: PROCEDURE

Total knee arthroplasty with a Fixed Bearing system.

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

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaber Ibrahim, M.D, Ph.D

Role: STUDY_DIRECTOR

Damascus University

Locations

Damascus university

Damascus, , Syria

Countries

Syria

References

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.

Reference Type: BACKGROUND

PMID: 14646769 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11716371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17621230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19092005 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23206460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24453622 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12571296 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22000572 (View on PubMed)

Other Identifiers

UDMS-Orthopedics-2-2023

Identifier Type: -

Identifier Source: org_study_id