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Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Patellar resurfacing with freehand technique
Patellar resurfacing with resection guide technique
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring patella, total knee arthroplasty, resection

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Sports Medicine, Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Freehand

Resection guide

Arm Description

Patellar resurfacing with freehand technique:Using freehand technique for patella preparation during total knee arthroplasty.

Patellar resurfacing with resection guide technique: Using patellar resection guide technique for patella preparation during total knee arthroplasty.

Outcomes

Primary Outcome Measures

Patellar tilt (PT)
The 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 Outcome Measures

Knee Society Score (KSS)
The 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.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The 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)
Pain rating scales.Scale Name:score scale range:0~100,and a higher values represent a worse outcome
Short Form-36 (SF-36)
The 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.
leg alignment
Radiographic 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.
prosthetic position
Radiographic 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 motion
Functional evaluation:it is measured by a blinded observer using goniometer.
patellar displacement (PD)
The 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.

Full Information

First Posted
October 11, 2014
Last Updated
June 15, 2017
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02268097
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 29, 2014 (Actual)
Primary Completion Date
July 15, 2017 (Anticipated)
Study Completion Date
July 15, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
patella, total knee arthroplasty, resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Freehand
Arm Type
Experimental
Arm Description
Patellar resurfacing with freehand technique:Using freehand technique for patella preparation during total knee arthroplasty.
Arm Title
Resection guide
Arm Type
Active Comparator
Arm Description
Patellar resurfacing with resection guide technique: Using patellar resection guide technique for patella preparation during total knee arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
Patellar resurfacing with freehand technique
Intervention Description
Preparing patellar resurfacing during total knee arthroplasty with freehand
Intervention Type
Procedure
Intervention Name(s)
Patellar resurfacing with resection guide technique
Intervention Description
Preparing patellar resurfacing during total knee arthroplasty with a resection guide
Primary Outcome Measure Information:
Title
Patellar tilt (PT)
Description
The 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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Knee Society Score (KSS)
Description
The 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.
Time Frame
1 year
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
The 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.
Time Frame
1 year
Title
visual analogue pain scale (VAS)
Description
Pain rating scales.Scale Name:score scale range:0~100,and a higher values represent a worse outcome
Time Frame
1 year
Title
Short Form-36 (SF-36)
Description
The 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.
Time Frame
1 year
Title
leg alignment
Description
Radiographic 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.
Time Frame
1 year
Title
prosthetic position
Description
Radiographic 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).
Time Frame
1 year
Title
Rang of motion
Description
Functional evaluation:it is measured by a blinded observer using goniometer.
Time Frame
1 year
Title
patellar displacement (PD)
Description
The 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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-Kuo Yu, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24706154
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.
Results Reference
background
PubMed Identifier
22204002
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.
Results Reference
background
PubMed Identifier
23299953
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.
Results Reference
background
PubMed Identifier
8436994
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.
Results Reference
background
PubMed Identifier
30539221
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.
Results Reference
derived

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Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

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