Back to resultsComparison of Three Knee Replacements
Primary Purpose
Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
NexGen
Persona
PFC
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- patients undergoing total knee replacement surgery for primary osteoarthritis
- no previous open major surgery in the joint ( e.g. osteotomy)
- unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future
- patients living in the local hospital district (Pirkanmaa Hospital District)
- Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs
Exclusion Criteria:
- Unwilling to provide informed consent
- > 15 degrees varus or valgus, or >15 degree fixed flexion deformity
- predominantly patellofemoral osteoarthritis
- Physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
Sites / Locations
- Coxa, Hospital for Joint Replacement
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
PFC Total Knee Replacement
NexGen Total Knee Replacement
Persona Total Knee Replacement
Arm Description
PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
Outcomes
Primary Outcome Measures
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Oxford Knee Score (OKS)
Secondary Outcome Measures
Changes in PROMs, Functional improvement
Forgotten Joint Score (FJS)
Changes in health-related quality of life (HRQoL)
15D
Changes in activity rating scale
UCLA activity score
Changes in pain scale measurement
VAS pain scale
Full Information
NCT ID
NCT03339557
First Posted
November 7, 2017
Last Updated
February 1, 2019
Sponsor
Coxa, Hospital for Joint Replacement
1. Study Identification
Unique Protocol Identification Number
NCT03339557
Brief Title
Comparison of Three Knee Replacements
Official Title
Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coxa, Hospital for Joint Replacement
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present randomized controlled trial is designed to compare one novel total knee replacement (TKR) design and two conventional TKR designs in terms of functional outcome. 80 patients will be randomized in each of the three arms (240 altogether).
Detailed Description
The study will compare the short-term functional outcome (at 2 years) of TKR performed with a novel TKR design (Persona , Zimmer, Warsaw, IN, USA) against TKRs performed with two conventional designs (PFC, DePuy, Warsaw, IN, USA and Nexgen, Zimmer, Warsaw, IN, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be recruited from Coxa outpatient clinic according to inclusion and exclusion criteria. The participating orthopedic surgeons will recruit patients along their out-patient work. The indications for the surgical treatment in the study will follow the routine clinical guidelines of the hospital. When TKR surgery is decided, the eligible patients will be informed and those willing to participate will be randomized into one of the three implant groups.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Patients will be operated upon using the implant allocated in randomization. Participants are blinded to the implant design used for their operation. Staff at the ward is also blinded. And the physiotherapists conducting the follow-up visits (at 2-3 months, 1 year and 2 years, i.e. the outcome assessors) are also blinded to the allocation.
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PFC Total Knee Replacement
Arm Type
Active Comparator
Arm Description
PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Arm Title
NexGen Total Knee Replacement
Arm Type
Active Comparator
Arm Description
NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.
Arm Title
Persona Total Knee Replacement
Arm Type
Active Comparator
Arm Description
Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.
Intervention Type
Device
Intervention Name(s)
NexGen
Intervention Description
Comparing two conventional designs and one novel design
Intervention Type
Device
Intervention Name(s)
Persona
Intervention Description
Comparing two conventional designs and one novel design
Intervention Type
Device
Intervention Name(s)
PFC
Intervention Description
Comparing two conventional designs and one novel design
Primary Outcome Measure Information:
Title
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Description
Oxford Knee Score (OKS)
Time Frame
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary Outcome Measure Information:
Title
Changes in PROMs, Functional improvement
Description
Forgotten Joint Score (FJS)
Time Frame
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Title
Changes in health-related quality of life (HRQoL)
Description
15D
Time Frame
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Title
Changes in activity rating scale
Description
UCLA activity score
Time Frame
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Title
Changes in pain scale measurement
Description
VAS pain scale
Time Frame
preoperative, postoperative at 2-3 months, at 1 year and at 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing total knee replacement surgery for primary osteoarthritis
no previous open major surgery in the joint ( e.g. osteotomy)
unilateral operative treatment, with no plans for surgical treatment of the contralateral knee in the near future
patients living in the local hospital district (Pirkanmaa Hospital District)
Kellgren-Lawrence grade 3-4 knee osteoarthritis in plain radiographs
Exclusion Criteria:
Unwilling to provide informed consent
> 15 degrees varus or valgus, or >15 degree fixed flexion deformity
predominantly patellofemoral osteoarthritis
Physical, emotional or neurological conditions that would compromise the patient´s compliance with postoperative rehabilitation and follow-up (e.g. drug or alcohol abuse, serious mental illness, general neurological conditions such as Parkinson, MS, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tero Irmola, MD
Organizational Affiliation
Coxa, Hospital for Joint Replacement
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coxa, Hospital for Joint Replacement
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33101
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15118039
Citation
Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012.
Results Reference
background
PubMed Identifier
17453401
Citation
Rasanen P, Paavolainen P, Sintonen H, Koivisto AM, Blom M, Ryynanen OP, Roine RP. Effectiveness of hip or knee replacement surgery in terms of quality-adjusted life years and costs. Acta Orthop. 2007 Feb;78(1):108-15. doi: 10.1080/17453670610013501.
Results Reference
background
PubMed Identifier
23307684
Citation
Jenkins PJ, Clement ND, Hamilton DF, Gaston P, Patton JT, Howie CR. Predicting the cost-effectiveness of total hip and knee replacement: a health economic analysis. Bone Joint J. 2013 Jan;95-B(1):115-21. doi: 10.1302/0301-620X.95B1.29835.
Results Reference
background
PubMed Identifier
17403800
Citation
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Results Reference
background
PubMed Identifier
19844772
Citation
Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
Results Reference
background
PubMed Identifier
20798443
Citation
Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
Results Reference
background
PubMed Identifier
22357571
Citation
Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.
Results Reference
background
PubMed Identifier
24262431
Citation
Giesinger K, Hamilton DF, Jost B, Holzner B, Giesinger JM. Comparative responsiveness of outcome measures for total knee arthroplasty. Osteoarthritis Cartilage. 2014 Feb;22(2):184-9. doi: 10.1016/j.joca.2013.11.001. Epub 2013 Nov 18.
Results Reference
background
PubMed Identifier
23109630
Citation
Hamilton DF, Gaston P, Simpson AH. Is patient reporting of physical function accurate following total knee replacement? J Bone Joint Surg Br. 2012 Nov;94(11):1506-10. doi: 10.1302/0301-620X.94B11.30081.
Results Reference
background
PubMed Identifier
22000572
Citation
Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
Results Reference
background
PubMed Identifier
23688851
Citation
Thienpont E, Opsomer G, Koninckx A, Houssiau F. Joint awareness in different types of knee arthroplasty evaluated with the Forgotten Joint score. J Arthroplasty. 2014 Jan;29(1):48-51. doi: 10.1016/j.arth.2013.04.024. Epub 2013 May 18.
Results Reference
background
PubMed Identifier
24269097
Citation
Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.
Results Reference
background
PubMed Identifier
24201900
Citation
Grosu I, Lavand'homme P, Thienpont E. Pain after knee arthroplasty: an unresolved issue. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1744-58. doi: 10.1007/s00167-013-2750-2. Epub 2013 Nov 8.
Results Reference
background
PubMed Identifier
18679762
Citation
Singh JA, Gabriel S, Lewallen D. The impact of gender, age, and preoperative pain severity on pain after TKA. Clin Orthop Relat Res. 2008 Nov;466(11):2717-23. doi: 10.1007/s11999-008-0399-9. Epub 2008 Aug 5.
Results Reference
background
PubMed Identifier
23702267
Citation
Perez-Prieto D, Gil-Gonzalez S, Pelfort X, Leal-Blanquet J, Puig-Verdie L, Hinarejos P. Influence of depression on total knee arthroplasty outcomes. J Arthroplasty. 2014 Jan;29(1):44-7. doi: 10.1016/j.arth.2013.04.030. Epub 2013 May 20.
Results Reference
background
PubMed Identifier
24493186
Citation
Hanusch BC, O'Connor DB, Ions P, Scott A, Gregg PJ. Effects of psychological distress and perceptions of illness on recovery from total knee replacement. Bone Joint J. 2014 Feb;96-B(2):210-6. doi: 10.1302/0301-620X.96B2.31136.
Results Reference
background
PubMed Identifier
25339125
Citation
Dowsey MM, Nikpour M, Dieppe P, Choong PF. Associations between pre-operative radiographic osteoarthritis severity and pain and function after total hip replacement : Radiographic OA severity predicts function after THR. Clin Rheumatol. 2016 Jan;35(1):183-9. doi: 10.1007/s10067-014-2808-7. Epub 2014 Oct 24.
Results Reference
background
PubMed Identifier
23573200
Citation
Keurentjes JC, Fiocco M, So-Osman C, Onstenk R, Koopman-Van Gemert AW, Poll RG, Kroon HM, Vliet Vlieland TP, Nelissen RG. Patients with severe radiographic osteoarthritis have a better prognosis in physical functioning after hip and knee replacement: a cohort-study. PLoS One. 2013;8(4):e59500. doi: 10.1371/journal.pone.0059500. Epub 2013 Apr 3.
Results Reference
background
PubMed Identifier
24187370
Citation
Berend KR, Lombardi AV Jr, Adams JB. Which total knee replacement implant should I pick? Correcting the pathology: the role of knee bearing designs. Bone Joint J. 2013 Nov;95-B(11 Suppl A):129-32. doi: 10.1302/0301-620X.95B11.32835.
Results Reference
background
PubMed Identifier
23997134
Citation
van der Voort P, Pijls BG, Nouta KA, Valstar ER, Jacobs WC, Nelissen RG. A systematic review and meta-regression of mobile-bearing versus fixed-bearing total knee replacement in 41 studies. Bone Joint J. 2013 Sep;95-B(9):1209-16. doi: 10.1302/0301-620X.95B9.30386.
Results Reference
background
PubMed Identifier
24981991
Citation
Becker R, Hirschmann MT, Karlsson J. Does implant design and surgical technique improve the clinical outcome in total knee arthroplasty? Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1716-8. doi: 10.1007/s00167-014-3145-8. No abstract available.
Results Reference
background
PubMed Identifier
24903823
Citation
Nunley RM, Nam D, Berend KR, Lombardi AV, Dennis DA, Della Valle CJ, Barrack RL. New total knee arthroplasty designs: do young patients notice? Clin Orthop Relat Res. 2015 Jan;473(1):101-8. doi: 10.1007/s11999-014-3713-8.
Results Reference
background
PubMed Identifier
22844046
Citation
Baker PN, Deehan DJ, Lees D, Jameson S, Avery PJ, Gregg PJ, Reed MR. The effect of surgical factors on early patient-reported outcome measures (PROMS) following total knee replacement. J Bone Joint Surg Br. 2012 Aug;94(8):1058-66. doi: 10.1302/0301-620X.94B8.28786.
Results Reference
background
PubMed Identifier
24502700
Citation
Piepers MJ, van Hove RP, van den Bekerom MP, Nolte PA. Do refinements to original designs improve outcome of total knee replacement? A retrospective cohort study. J Orthop Surg Res. 2014 Feb 6;9:7. doi: 10.1186/1749-799X-9-7.
Results Reference
background
PubMed Identifier
20932707
Citation
Pritchett JW. Patients prefer a bicruciate-retaining or the medial pivot total knee prosthesis. J Arthroplasty. 2011 Feb;26(2):224-8. doi: 10.1016/j.arth.2010.02.012. Epub 2010 Oct 6.
Results Reference
background
PubMed Identifier
31604440
Citation
Irmola T, Kangas J, Eskelinen A, Niemelainen M, Huhtala H, Mattila VM, Moilanen T. Functional outcome of total knee replacement: a study protocol for a prospective, double-blinded, parallel-group randomized, clinical controlled trial of novel, personalized and conventional implants. BMC Musculoskelet Disord. 2019 Oct 12;20(1):443. doi: 10.1186/s12891-019-2830-7.
Results Reference
derived
Learn more about this trial
Comparison of Three Knee Replacements
We'll reach out to this number within 24 hrs