Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02268097
• Other study ID #: YJK-003
• Status: Active, not recruiting
• Phase: N/A
• First received: October 11, 2014
• Last updated: June 15, 2017
• Start date: October 29, 2014
• Est. completion date: July 15, 2017

Study information

• Verified date: October 2014
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Patellar resurfacing with freehand technique
Preparing patellar resurfacing during total knee arthroplasty with freehand
• Patellar resurfacing with resection guide technique
Preparing patellar resurfacing during total knee arthroplasty with a resection guide

Locations

Country	Name	City	State
China	Institute of Sports Medicine, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

Bartlett DH, Franzen J. Accurate preparation of the patella during total knee arthroplasty. J Arthroplasty. 1993 Feb;8(1):75-82. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	visual analogue pain scale (VAS)	Pain rating scales.Scale Name:score scale range:0~100,and a higher values represent a worse outcome	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	prosthetic position	Radiographic evaluation:The following parameters were measured: the coronal femoral component angle (a; angle between femoral shaft and transcondylar line of the femoral component); coronal tibial component angle (ß; angle between the mechanical axis of the tibia and tibial base plate); sagittal femoral component angle (?; angle of femoral component flexion); and sagittal tibial component angle (d; posterior slope angle of the tibial component).	1 year
Secondary	Rang of motion	Functional evaluation:it is measured by a blinded observer using goniometer.	1 year
Secondary	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.	1 year