Anterior Knee Pain in Mobile Bearing Versus Fixed Bearing in TKA

NCT05696418 | Completed

• 1 other identifier: UDMS-Orthopedics-2-2023
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Diseases; Arthritis Knee; Arthroplasty Complications

Keywords

Mobile bearing; Fixed bearing; Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Anterior knee pain

  Anterior knee pain will be assessed by questionnaire.

  1-2 years after surgery

Secondary Outcomes (3)

• Knee Society Score (KSS)

  1-2 years after surgery

• Forgotten Joint Scale (FJS)

  1-2 years after surgery

• perioperative complications

  assessed within two weeks intervals until 6 months after surgery

Study Arms (2)

Mobile Bearing Design TKA

EXPERIMENTAL

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

Procedure: Total knee arthroplasty with a Mobile Bearing system.

Fixed Bearing Design TKA

EXPERIMENTAL

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

Procedure: Total knee arthroplasty with a Fixed Bearing system.

Interventions

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.

Mobile Bearing Design TKA

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.

Fixed Bearing Design TKA

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with expected primary total knee arthroplasty

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus university

Damascus, Syria

Location

Related Publications (8)

• 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.

  PMID: 14646769 BACKGROUND

• 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.

  PMID: 11716371 BACKGROUND

• 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.

  PMID: 17621230 BACKGROUND

• 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.

  PMID: 19092005 BACKGROUND

• 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.

  PMID: 23206460 BACKGROUND

• 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.

  PMID: 24453622 BACKGROUND

• 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.

  PMID: 12571296 BACKGROUND

• 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.

  PMID: 22000572 BACKGROUND

MeSH Terms

Conditions

Joint Diseases

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Jaber Ibrahim, M.D, Ph.D

  Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 25, 2023
• Study Start: January 15, 2021
• Primary Completion: March 15, 2024
• Study Completion: March 25, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)