Osteoarthritis, KneeNCT03339557
Comparison of Three Knee Replacements
A study testing NexGen, Persona and PFC in people with Osteoarthritis, Knee and Arthroplasty, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
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). Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement
- What is being tested?
- NexGen, Persona and PFC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFinland
- Study dates
- 1 Sep 2015to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
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).
- Conditions
- Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement
- Being tested
- NexGen, Persona, PFC
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexGenDevice
Comparing two conventional designs and one novel design
PersonaDevice
Comparing two conventional designs and one novel design
PFCDevice
Comparing two conventional designs and one novel design
| Study group | Role | What they receive |
|---|---|---|
| PFC Total Knee Replacement | Active comparator | PFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. Receives: Device: NexGen; Device: Persona |
| NexGen Total Knee Replacement | Active comparator | NexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. Receives: Device: Persona; Device: PFC |
| Persona Total Knee Replacement | Active comparator | Persona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital. Receives: Device: NexGen; Device: PFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Oxford Knee Score (OKS)
Measured: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Secondary outcomes (4)
Changes in PROMs, Functional improvement
Forgotten Joint Score (FJS)
Measured: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in health-related quality of life (HRQoL)
15D
Measured: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in activity rating scale
UCLA activity score
Measured: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in pain scale measurement
VAS pain scale
Measured: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Sep 2015
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tero Irmola, Coxa, Hospital for Joint Replacement
- Investigators
- Tero Irmola, MD, Principal investigator, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339557
- Sponsor's protocol ID
- R15053
- Status last verified
- Feb 2019
- First submitted
- 7 Nov 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 15118039Rasanen 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 17453401Jenkins 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 23307684Kurtz 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 17403800Bourne 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 19844772Scott 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 20798443Beswick 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 22357571Giesinger 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 24262431Hamilton 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 23109630Behrend 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 22000572Thienpont 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 23688851Klit 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 24269097Grosu 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 24201900Singh 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 18679762Perez-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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome of Total Knee Replacement. Randomized Clinical Controlled Trial of Novel and Conventional Implants
- ClinicalTrials.gov ID
- NCT03339557
- Acronym / sponsor ID
- R15053
- Conditions
- Osteoarthritis, Knee, Arthroplasty, Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| PFC Total Knee Replacement | Active comparator | Device: NexGen, Device: PersonaPFC, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. |
| NexGen Total Knee Replacement | Active comparator | Device: Persona, Device: PFCNexGen, Conventional design Perioperative treatment will be carried out according to routine protocol of the hospital. |
| Persona Total Knee Replacement | Active comparator | Device: NexGen, Device: PFCPersona, Novel design Perioperative treatment will be carried out according to routine protocol of the hospital. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NexGenComparing two conventional designs and one novel design | Device | PFC Total Knee Replacement, Persona Total Knee Replacement |
| PersonaComparing two conventional designs and one novel design | Device | NexGen Total Knee Replacement, PFC Total Knee Replacement |
| PFCComparing two conventional designs and one novel design | Device | NexGen Total Knee Replacement, Persona Total Knee Replacement |
Primary outcome
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Oxford Knee Score (OKS)
4 secondary outcomes
Changes in PROMs, Functional improvement
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in health-related quality of life (HRQoL)
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in activity rating scale
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Changes in pain scale measurement
Time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Background: PubMed 15118039Ethgen 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.
- Background: PubMed 17453401Rasanen 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.
- Background: PubMed 23307684Jenkins 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.
- Background: PubMed 17403800Kurtz 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.
- Background: PubMed 19844772Bourne 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.
- Background: PubMed 20798443Scott 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.
- Background: PubMed 22357571Beswick 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.
- Background: PubMed 24262431Giesinger 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.
- Background: PubMed 23109630Hamilton 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.
- Background: PubMed 22000572Behrend 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.
- Background: PubMed 23688851Thienpont 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.
- Background: PubMed 24269097Klit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Irmola, MD principal investigator
Coxa, Hospital for Joint Replacement
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGen, Persona and PFC in people with Osteoarthritis, Knee and Arthroplasty, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patient reported outcome measures scores (PROMs), Functional improvement (time frame: preoperative, postoperative at 2-3 months, at 1 year and at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339557, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.