NCT02268097

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

October 29, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

June 16, 2017

Status Verified

October 1, 2014

Enrollment Period

2.7 years

First QC Date

October 11, 2014

Last Update Submit

June 15, 2017

Conditions

Osteoarthritis

Keywords

patellatotal knee arthroplastyresection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Knee Society Score (KSS)

    1 year

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    1 year

  • visual analogue pain scale (VAS)

    1 year

  • Short Form-36 (SF-36)

    1 year

  • leg alignment

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Freehand

EXPERIMENTAL

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

Procedure: Patellar resurfacing with freehand technique

Resection guide

ACTIVE COMPARATOR

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

Procedure: Patellar resurfacing with resection guide technique

Interventions

Patellar resurfacing with freehand techniquePROCEDURE

Preparing patellar resurfacing during total knee arthroplasty with freehand

Freehand
Patellar resurfacing with resection guide techniquePROCEDURE

Preparing patellar resurfacing during total knee arthroplasty with a resection guide

Resection guide

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (5)

  • 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.

    PMID: 24706154BACKGROUND

  • 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.

    PMID: 22204002BACKGROUND

  • 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.

    PMID: 23299953BACKGROUND

  • 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.

    PMID: 8436994BACKGROUND

  • 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.

    PMID: 30539221DERIVED

MeSH Terms

Conditions

OsteoarthritisPatella Fracture

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesKnee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Jia-Kuo Yu, Doctor

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peking University Third Hospital

Study Record Dates

First Submitted

October 11, 2014

First Posted

October 20, 2014

Study Start

October 29, 2014

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

June 16, 2017

Record last verified: 2014-10

Locations

CN(1)