NCT06811506

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

January 31, 2025

Last Update Submit

February 5, 2025

Conditions

Osteoarthritis (OA) of the KneeOA Knee

Keywords

patella crepitationcrepituspatella clunk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Range of motion

    From enrollment (preoperative measurement) to the end of postoperative follow-up (1 year)

  • anterior knee pain

    follow up 6 months and 12 months

  • Feller's patella score

    follow up 6 months and 12 months

  • Knee society score

    follow up 6 months and 12 months

  • Kujala score

    follow up 6 months and 12 months

  • +7 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR
Procedure: Anatomical size patella component

Group 2

ACTIVE COMPARATOR
Procedure: Reduced size patella component

Interventions

Anatomical size patella componentPROCEDURE

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.

Group 1
Reduced size patella componentPROCEDURE

The same procedure of patella resurfacing as control group was done, then 3 mm reduced size patella component was used in the intervention group.

Group 2

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Khlong Nueng, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (6)

  • 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.

    PMID: 35962233BACKGROUND

  • 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.

    PMID: 32274550BACKGROUND

  • 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.

    PMID: 24605184BACKGROUND

  • 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.

    PMID: 26948175BACKGROUND

  • 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.

    PMID: 20706813BACKGROUND

  • 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.

    PMID: 34116913BACKGROUND

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

July 17, 2020

Primary Completion

July 10, 2023

Study Completion

August 31, 2023

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

TH(1)