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Osteoarthritis (OA) of the KneeNCT06811506

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

A study testing Anatomical size patella component and Reduced size patella component in people with Osteoarthritis (OA) of the Knee and OA Knee, run by Thammasat University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Osteoarthritis (OA) of the Knee, OA Knee
What is being tested?
Anatomical size patella component and Reduced size patella component
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteThailand
Study dates
17 Jul 2020to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Thammasat University

    Khlong Nueng, Changwat Pathum Thani, 12120

Other trials in Thailand

About this study

Official title: 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.

Read the 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.

Being tested
Anatomical size patella component, Reduced size patella component
Keywords
patella crepitation, crepitus, patella clunk
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anatomical size patella componentProcedure or surgery

    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.

  • Reduced size patella componentProcedure or surgery

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

Study groups in NCT06811506
Study groupRoleWhat they receive
Group 1Active comparatorNot described
Receives: Procedure: Anatomical size patella component
Group 2Active comparatorNot described
Receives: Procedure: Reduced size patella component

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From postoperative follow-up 2 weeks to 1 year

Secondary outcomes (12)

  1. Range of motion

    Range of motion (flexion, extension) of the knee measure by long arm goniometer (record in degrees)

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

  2. 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)

    Measured: follow up 6 months and 12 months

  3. 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.

    Measured: follow up 6 months and 12 months

  4. 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.

    Measured: follow up 6 months and 12 months

  5. 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.

    Measured: follow up 6 months and 12 months

  6. 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.

    Measured: preoperative and follow up 6 months

  7. 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.

    Measured: preoperative and follow up 6 months

  8. 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.

    Measured: preoperative and follow up 6 months

  9. modified Insall salvati ratio

    modified Insall-Salvati ratio = modified Patella tendon length / modified patella height

    Measured: preoperative and follow up 6 months

  10. 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.

    Measured: preoperative and follow up 6 months

  11. Patella tilt

    The angle between the transverse axis of the patella and the anterior intercondylar line. Measure in degrees on film knee patella skyline.

    Measured: preoperative and follow up 6 months

  12. Complication

    Surgical site infection, deep infection or wound complication

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start17 Jul 2020
  3. Primary completion10 Jul 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06811506
Sponsor's protocol ID
Patella crep TUH
Status last verified
Feb 2025
First submitted
31 Jan 2025
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 35962233

  • 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.

    PubMed 32274550

  • 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.

    PubMed 24605184

  • 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.

    PubMed 26948175

  • 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.

    PubMed 20706813

  • 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.

    PubMed 34116913

Questions about this trial

What is this clinical trial studying?

A study testing Anatomical size patella component and Reduced size patella component in people with Osteoarthritis (OA) of the Knee and OA Knee, run by Thammasat University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patella crepitation (time frame: From postoperative follow-up 2 weeks to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06811506, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.

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