Comparison of Three Knee Replacements

Osteoarthritis, Knee Clinical Trial

Official title:

Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03339557
• Other study ID #: R15053
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2019
• Source: Coxa, Hospital for Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Arthroplasty
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Replacement

Intervention

Device:
• NexGen
Comparing two conventional designs and one novel design
• Persona
Comparing two conventional designs and one novel design
• PFC
Comparing two conventional designs and one novel design

Locations

Country	Name	City	State
Finland	Coxa, Hospital for Joint Replacement	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Coxa, Hospital for Joint Replacement

Country where clinical trial is conducted

Finland, 

References & Publications (25)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Ethgen O, Bruyère 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-A(5):963-74. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Keurentjes JC, Fiocco M, So-Osman C, Onstenk R, Koopman-Van Gemert AW, Pöll 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. — View 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. — View 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. — View 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. — View Citation

Pérez-Prieto D, Gil-González S, Pelfort X, Leal-Blanquet J, Puig-Verdié 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. — View 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. — View 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. — View Citation

Räsänen P, Paavolainen P, Sintonen H, Koivisto AM, Blom M, Ryynänen 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in patient reported outcome measures scores (PROMs), Functional improvement	Oxford Knee Score (OKS)	preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary	Changes in PROMs, Functional improvement	Forgotten Joint Score (FJS)	preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary	Changes in health-related quality of life (HRQoL)	15D	preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary	Changes in activity rating scale	UCLA activity score	preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary	Changes in pain scale measurement	VAS pain scale	preoperative, postoperative at 2-3 months, at 1 year and at 2 years