Clinical trial NCT02268097: Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty
Official title: Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: patella
total knee arthroplasty
resection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 101
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.

Detailed description: With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also compared between the two groups.

Eligibility criteria: Inclusion Criteria:

diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with \<20° varus or \<15° valgus deformity patellar thickness is more than 21mm

Exclusion Criteria:

restricted motion (flexion contracture of \>25°) patella alta (Insall-Salvati ratio of \<0.6) history of previous knee surgery

Primary outcomes:
measure: Patellar tilt (PT)
timeFrame: 1 year
Secondary outcomes:
measure: Knee Society Score (KSS)
timeFrame: 1 year
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 1 year
measure: visual analogue pain scale (VAS)
timeFrame: 1 year
measure: Short Form-36 (SF-36)
timeFrame: 1 year
measure: leg alignment
timeFrame: 1 year
measure: prosthetic position
timeFrame: 1 year
measure: Rang of motion
timeFrame: 1 year
measure: patellar displacement (PD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Sports Medicine, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jia-Kuo Yu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel MP, Parratte S, Budhiparama NC. The patella in total knee arthroplasty: to resurface or not is the question. Curr Rev Musculoskelet Med. 2014 Jun;7(2):117-24. doi: 10.1007/s12178-014-9212-4.
citation: Breeman S, Campbell M, Dakin H, Fiddian N, Fitzpatrick R, Grant A, Gray A, Johnston L, Maclennan G, Morris R, Murray D; KAT Trial Group. Patellar resurfacing in total knee replacement: five-year clinical and economic results of a large randomized controlled trial. J Bone Joint Surg Am. 2011 Aug 17;93(16):1473-81. doi: 10.2106/JBJS.J.00725.
citation: Camp CL, Bryan AJ, Walker JA, Trousdale RT. Surgical technique for symmetric patellar resurfacing during total knee arthroplasty. J Knee Surg. 2013 Aug;26(4):281-4. doi: 10.1055/s-0032-1330056. Epub 2013 Jan 8.
citation: Bartlett DH, Franzen J. Accurate preparation of the patella during total knee arthroplasty. J Arthroplasty. 1993 Feb;8(1):75-82. doi: 10.1016/s0883-5403(06)80111-7.
citation: Yuan F, Sun Z, Wang H, Chen Y, Yu J. Clinical and radiologic outcomes of two patellar resection techniques during total knee arthroplasty: a prospective randomized controlled study. Int Orthop. 2019 Oct;43(10):2293-2301. doi: 10.1007/s00264-018-4264-5. Epub 2018 Dec 11.