Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

NCT ID: NCT02268097

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-29

Study Completion Date

2017-07-15

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Freehand

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

Group Type EXPERIMENTAL

Patellar resurfacing with freehand technique

Intervention Type PROCEDURE

Preparing patellar resurfacing during total knee arthroplasty with freehand

Resection guide

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

Group Type ACTIVE_COMPARATOR

Patellar resurfacing with resection guide technique

Intervention Type PROCEDURE

Preparing patellar resurfacing during total knee arthroplasty with a resection guide

Interventions

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Patellar resurfacing with freehand technique

Preparing patellar resurfacing during total knee arthroplasty with freehand

Intervention Type PROCEDURE

Patellar resurfacing with resection guide technique

Preparing patellar resurfacing during total knee arthroplasty with a resection guide

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jia-kuo yu

Peking University Third Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jia-Kuo Yu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 24706154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22204002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23299953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8436994 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30539221 (View on PubMed)

Other Identifiers

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YJK-003

Identifier Type: -

Identifier Source: org_study_id

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