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Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty.A Prospective, Randomized, Double-blind Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02268097
Enrollment
101
Registered
2014-10-20
Start date
2014-10-29
Completion date
2017-07-15
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

patella, total knee arthroplasty, resection

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.

Interventions

PROCEDUREPatellar resurfacing with freehand technique

Preparing patellar resurfacing during total knee arthroplasty with freehand

PROCEDUREPatellar resurfacing with resection guide technique

Preparing patellar resurfacing during total knee arthroplasty with a resection guide

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patellar tilt (PT)1 yearThe patellar tilt is the angle between the transverse axis of the patella and The patellar tilt is the angle between the transverse axis of the patella and the anterior intercondylar line.The PT was assessed by a blinded observer using 30° skyline radiographs.

Secondary

MeasureTime frameDescription
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)1 yearThe Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index is a tested questionnaire to assess symptoms and physical functional disability in patients with OA of the knee.Scale Name:score scale range:0\ 100,and a lesser values represent a better outcome.
visual analogue pain scale (VAS)1 yearPain rating scales.Scale Name:score scale range:0\ 100,and a higher values represent a worse outcome
Short Form-36 (SF-36)1 yearThe SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. A higher values represent a better outcome.
Knee Society Score (KSS)1 yearThe Knee Society's Knee Scoring System (KSS) has served as a simple, objective way to measure a patient's functional ability before and after total knee arthroplasty (TKA).Scale Name:score scale range:0\ 100,and a higher values represent a better outcome.
prosthetic position1 yearRadiographic evaluation:The following parameters were measured: the coronal femoral component angle (α; angle between femoral shaft and transcondylar line of the femoral component); coronal tibial component angle (β; angle between the mechanical axis of the tibia and tibial base plate); sagittal femoral component angle (γ; angle of femoral component flexion); and sagittal tibial component angle (δ; posterior slope angle of the tibial component).
Rang of motion1 yearFunctional evaluation:it is measured by a blinded observer using goniometer.
patellar displacement (PD)1 yearThe patellar displacement is the lateral displacement of the median ridge of the patella from the intercondylar sulcus of the femur.The PD was assessed by a blinded observer using 30° skyline radiographs.
leg alignment1 yearRadiographic evaluation:The measurements were made by a blinded observer, in accordance with the principles stipulated by the Knee Society, by using computer-generated data derived from the digital radiographs.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026