ClinicalTrials.gg
Status unknownNCT03339557Updated Feb 4, 2019

Comparison of Three Knee Replacements

An interventional study of NexGen and Persona in Osteoarthritis, Knee, Arthroplasty and Total Knee Replacement, sponsored by Coxa, Hospital for Joint Replacement. Status unknown at 1 site in Finland. Open to participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Coxa, Hospital for Joint Replacement · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Sep 2015, registered Nov 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies in Osteoarthritis, Knee with a site in Finland — none open to participants now, 1 under way, none of them phase 3. Osteoarthritis, Knee · Finland.

Enrollment
4th of 15
240 · median 140
Started
2015
with 1 other
No phase
10 of 16
none open now
Registered
12th of 16
by date
Lead sponsor
1 of 16
Coxa, Hospital for Joint Replacement

Among the 16 studies in Osteoarthritis, Knee with a site in Finland, this one is the 4th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2015, is one of 10 with no phase, and was the 12th registered.

Osteoarthritis, Knee

3,294 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

None of the 16 studies in Osteoarthritis, Knee with a site in Finland is open now. The open studies under Osteoarthritis, Knee, anywhere →

Who these studies take

Of the 383 Osteoarthritis, Knee studies recruiting now, 177 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 50 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Download CSVNarrow it in search →With an account: the 16 studies in Osteoarthritis, Knee with a site in Finland as a file.
02

Study 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).

Read the 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).

03

Conditions studied

  • Osteoarthritis, Knee
  • Arthroplasty
  • Total Knee Replacement
04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unwilling to provide
  • > 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.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    PFC Total Knee Replacement

    PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.

    Device: NexGen · Device: Persona

  • Active comparator
    NexGen Total Knee Replacement

    NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital.

    Device: Persona · Device: PFC

  • Active comparator
    Persona Total Knee Replacement

    Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital.

    Device: NexGen · Device: PFC

Interventions

  • DeviceNexGen

    Comparing two conventional designs and one novel design

  • DevicePersona

    Comparing two conventional designs and one novel design

  • DevicePFC

    Comparing two conventional designs and one novel design

06

What researchers measure

Primary outcomes

  1. Changes in patient reported outcome measures scores (PROMs), Functional improvement

    Oxford Knee Score (OKS)

    Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years

Secondary outcomes

  1. Changes in PROMs, Functional improvement

    Forgotten Joint Score (FJS)

    Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years

  2. Changes in health-related quality of life (HRQoL)

    15D

    Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years

  3. Changes in activity rating scale

    UCLA activity score

    Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years

  4. Changes in pain scale measurement

    VAS pain scale

    Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years

07

Study locations

1 site
  • Coxa, Hospital for Joint Replacement
    Tampere, Pirkanmaa 33101, Finland
08

References and documents

Publications

  • 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. PubMed 15118039 ↗
  • 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. PubMed 17453401 ↗
  • 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. PubMed 23307684 ↗
  • 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. PubMed 17403800 ↗
  • 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. PubMed 19844772 ↗
  • 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. PubMed 20798443 ↗
  • 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. PubMed 22357571 ↗
  • 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. PubMed 24262431 ↗
  • 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. PubMed 23109630 ↗
  • 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. PubMed 22000572 ↗
  • 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. PubMed 23688851 ↗
  • 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. PubMed 24269097 ↗
  • 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. PubMed 24201900 ↗
  • 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. PubMed 18679762 ↗
  • 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. PubMed 23702267 ↗
  • 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. PubMed 24493186 ↗
  • 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. PubMed 25339125 ↗
  • 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. PubMed 23573200 ↗
  • 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. PubMed 24187370 ↗
  • 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. PubMed 23997134 ↗
  • 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. PubMed 24981991 ↗
  • 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. PubMed 24903823 ↗
  • 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. PubMed 22844046 ↗
  • 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. PubMed 24502700 ↗
  • 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. PubMed 20932707 ↗
  • 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. PubMed 31604440 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2015 (actual). Primary completion is estimated for May 2021, 68 months after the start.

Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 68 months is above that.

Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2017
First posted
Nov 13, 2017
StartActual
Sep 1, 2015
Primary completionEst.
May 31, 2021
CompletionEst.
May 31, 2021
Last update
Feb 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03339557
Lead sponsor
Coxa, Hospital for Joint Replacement
Responsible party
Tero Irmola (orthopaedic surgeon, Coxa, Hospital for Joint Replacement) — Principal investigator
First posted
Nov 13, 2017
Start date
Sep 1, 2015
Primary completion
May 31, 2021 (estimated)
Completion
May 31, 2021 (estimated)
Last update
Feb 4, 2019

Study contacts

Tero Irmola, MD
principal investigator · Coxa, Hospital for Joint Replacement

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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