Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty.

Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty: a Prospective Randomize Control Trial.

The goal of this study is to compare the incidence of patella crepitation using different size of patella component in bilateral simultaneously total knee arthroplasty with patella resurfacing. The main question is does size of patella component effect the incidence of patella crepitus? In the control group, anatomically sized patella components were used, whereas the intervention group received 3 mm smaller, reduced-size patella components. Participants were scheduled for follow up examination 2 weeks, 6 weeks, 6 months and 1 year for incidence of the patella crepitation and other outcomes.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis (OA) of the Knee; OA Knee
• Intervention / Treatment: Procedure: Anatomical size patella component; Procedure: Reduced size patella component

Detailed Description

For decades, total knee arthroplasty (TKA) has been the treatment of choice for knee osteoarthritis, with posterior-stabilized (PS) systems showing excellent long-term outcomes. However, patellar crepitus is more common with PS TKA systems because the cam and post mechanism can entrap fibrosynovial tissue within the intercondylar box, causing crepitus or clunking. Patellar crepitus (PC) was defined as an audible grinding noise or palpable vibrations in the knee during active and passive range of motion, detected by the examiner's hand on the patient's patella and sometimes can be audible.

This study was designed as a single-center, prospective randomized controlled trial comparing anatomical and reduced size of patella component in patients who underwent sequential bilateral TKA with patella resurfacing under single anesthesia. All participants were blinded to their intervention. A total of 94 knees from 47 patients were randomly assigned to undergo TKA with an anatomically sized patella component in one knee and reduced-size patella component in another knee or vice versa.

Crepitus, as a primary outcome, was assessed at 2, 6, 24 and 48 weeks follow-up using a validated and standardized approach. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible). Secondary outcomes included anterior knee pain (AKP), Feller's patella score (FPS), Kujala score, knee society score (KSS), range of motion (ROM), radiographic findings, and complications. AKP was measured using a 10-cm visual analog scale (VAS) in 1-cm increments. Knee ROM was measured with a goniometer. Radiographic parameters were measured at 6 months postoperatively.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Pathum-Thani
    • Khlong nueng, Pathum-Thani, Thailand, 12120
      • Thammasat University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 50 and 80 years.
• American Society of Anesthesiologists (ASA) Classification 1 or 2.
• Diagnosed with primary knee osteoarthritis and requires bilateral total knee arthroplasty with patellar resurfacing.
• Participants can understand and consent to participate in the research project

Exclusion Criteria:

• Secondary knee osteoarthritis,
• Previous knee surgery or arthroscopic surgery
• Individuals who cannot undergo surgery due to underlying medical conditions.
• BMI > 40 kg/m2
• Infection around the knee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1	Procedure: Anatomical size patella component; After the patella was resurfaced, surgeon evaluated the symmetry through haptic feedback and assessed the thickness by measuring the distance from the anterior to posterior center of the patella. An inset, single pegged patella component was cemented after milling the patella. The patella was medialized as the patella bone would allow. Synovium laying on top of the femoral component with the knee in extension was routinely excised. Lateral facetectomy and restoration of native patella thickness were performed in all knees. In the control group, anatomically sized patella components were used.
Active Comparator: Group 2	Procedure: Reduced size patella component; The same procedure of patella resurfacing as control group was done, then 3 mm reduced size patella component was used in the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patella crepitation	Crepitus was assessed at each follow-up using a validated and standardized approach of physical examination. The patient lay supine with relaxed muscles while the examiner passively flexed and extended the knee through a 30-90° range at least three times. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible).	From postoperative follow-up 2 weeks to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	Range of motion (flexion, extension) of the knee measure by long arm goniometer (record in degrees)	From enrollment (preoperative measurement) to the end of postoperative follow-up (1 year)
anterior knee pain	Define as pain originate from anterior aspect of the knee including patellofemoral joint especially when perform active range of motion of the knee. Measure in scale (0 means best, 10 means worst)	follow up 6 months and 12 months
Feller's patella score	The questionnaire of Feller et al. [8] includes items on anterior knee pain, quadriceps strength, and ability to rise from a chair and climb stairs; these scores range from 3 to 30 points, with 30 points representing the best possible score.	follow up 6 months and 12 months
Knee society score	1. "Knee Score" section (7 items) and a 2. "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.	follow up 6 months and 12 months
Kujala score	13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. With 100 being the highest possible score. Lower scores reflect greater pain and disability.	follow up 6 months and 12 months
Posterior tibial slope	The angle of the tibial plateau or tibial component from anterior to posterior relative to the longitudinal axis of the tibia. Measure in degrees on film true lateral knee flexion 30 degrees.	preoperative and follow up 6 months
modified Patella tendon length	Measuring from the tibial tubercle's proximal point to the patella's distal articular facet. Measure in millimeters on film true lateral knee flexion 30 degrees.	preoperative and follow up 6 months
modified Patella height	Measured from the distal to the proximal point of the same facet. Measure in millimeters on film true lateral knee flexion 30 degrees.	preoperative and follow up 6 months
modified Insall salvati ratio	modified Insall-Salvati ratio = modified Patella tendon length / modified patella height	preoperative and follow up 6 months
Posterior femoral offset	Defined as the maximum thickness of posterior condyle / femoral component projecting to the tangent of the posterior cortex of femoral shaft. Measure in millimeters on film true lateral knee flexion 30 degrees.	preoperative and follow up 6 months
Patella tilt	The angle between the transverse axis of the patella and the anterior intercondylar line. Measure in degrees on film knee patella skyline.	preoperative and follow up 6 months
Complication	Surgical site infection, deep infection or wound complication	up to 12 months

Collaborators and Investigators

• Sponsor: Thammasat University
• Collaborators: Thammasat University Hospital

Publications and helpful links

General Publications

• Chumchuen S, Kanitnate S, Wattanasirisombat K, Tammachote N. Synovium removal from the articular side of the quadriceps tendon around the superior pole of patella reduces the crepitus after total knee arthroplasty. Int Orthop. 2022 Nov;46(11):2561-2567. doi: 10.1007/s00264-022-05539-2. Epub 2022 Aug 13.
• Joseph L, Batailler C, Roger J, Swan J, Servien E, Lustig S. Patellar component size effects patellar tilt in total knee arthroplasty with patellar resurfacing. Knee Surg Sports Traumatol Arthrosc. 2021 Feb;29(2):553-562. doi: 10.1007/s00167-020-05984-9. Epub 2020 Apr 9.
• Conrad DN, Dennis DA. Patellofemoral crepitus after total knee arthroplasty: etiology and preventive measures. Clin Orthop Surg. 2014 Mar;6(1):9-19. doi: 10.4055/cios.2014.6.1.9. Epub 2014 Feb 14.
• Ogawa H, Matsumoto K, Akiyama H. Effect of Patellar Resurfacing on Patellofemoral Crepitus in Posterior-Stabilized Total Knee Arthroplasty. J Arthroplasty. 2016 Aug;31(8):1792-6. doi: 10.1016/j.arth.2016.01.023. Epub 2016 Jan 21.
• Dennis DA, Kim RH, Johnson DR, Springer BD, Fehring TK, Sharma A. The John Insall Award: control-matched evaluation of painful patellar Crepitus after total knee arthroplasty. Clin Orthop Relat Res. 2011 Jan;469(1):10-7. doi: 10.1007/s11999-010-1485-3.
• Thiengwittayaporn S, Sumranwanich N, Hongku N, Sansawat P. Onlay Patellar Resurfacing in a Posterior-Stabilized Total Knee Arthroplasty Increases Patellar Crepitus Complication: A Randomized, Controlled Trial. J Arthroplasty. 2021 Oct;36(10):3443-3450. doi: 10.1016/j.arth.2021.05.031. Epub 2021 May 27.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2020
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: crepitus; patella crepitation; patella clunk
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: Patella crep TUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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.: No