Clinical trial NCT06811506: Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
OA Knee
Keywords: patella crepitation
crepitus
patella clunk
Lead sponsor: Thammasat University
Sponsor class: OTHER
Collaborators: name: Thammasat University Hospital
First posted: 2025-02-06
Enrollment: 94
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patella crepitation
timeFrame: From postoperative follow-up 2 weeks to 1 year
Secondary outcomes:
measure: Range of motion
timeFrame: From enrollment (preoperative measurement) to the end of postoperative follow-up (1 year)
measure: anterior knee pain
timeFrame: follow up 6 months and 12 months
measure: Feller's patella score
timeFrame: follow up 6 months and 12 months
measure: Knee society score
timeFrame: follow up 6 months and 12 months
measure: Kujala score
timeFrame: follow up 6 months and 12 months
measure: Posterior tibial slope
timeFrame: preoperative and follow up 6 months
measure: modified Patella tendon length
timeFrame: preoperative and follow up 6 months
measure: modified Patella height
timeFrame: preoperative and follow up 6 months
measure: modified Insall salvati ratio
timeFrame: preoperative and follow up 6 months
measure: Posterior femoral offset
timeFrame: preoperative and follow up 6 months
measure: Patella tilt
timeFrame: preoperative and follow up 6 months
measure: Complication
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Khlong nueng
country: Thailand
facility: Thammasat University
state: Pathum-Thani
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.