Knee OsteoarthritisNCT02965690
Kinematics of Contemporary Knee Arthroplasty
A study testing Zimmer Biomet NexGen CR and Medacta International GMK Sphere in people with Knee Osteoarthritis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Zimmer Biomet NexGen CR and Medacta International GMK Sphere
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with knee osteoarthritis
Who cannot join
- Preoperative severe deformity (Femoro-tibial angle < 175°or > 190° measured on a full-length leg image at weight bearing)
- Preoperative flexion contracture more than 15°
- Preoperative limited range of motion under anesthetics (less than 110°)
- Less than 50 or more than 75 years of age at the time of surgery
- Use of walking aids because of other musculoskeletal and neuromuscular problems
- Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
Show all 13Show fewer
- Revision arthroplasty
- Obesity with BMI>35
- Impaired collateral ligaments
- Postoperative KOOS score less than 80
- Malposition of femoral and tibial implants (Internally rotated or more han 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement)
- Limb surgery within 3 months before the analysis
- Postoperative revision surgery due to deep wound infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of in Vivo Kinematics of Different Implants in ACL-sacrificing vs. Medially Stabilized Arthroplasty (Implant Design Study)
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.
Read the detailed description
Worldwide the number of patients requiring treatment for osteoarthritis is increasing due to increasing obesity, an ageing population and a high demanding younger population. Learmonth describes hip arthroplasty as the "operation of the century" because patients are highly satisfied with pain relief and function after the procedure. Knee arthroplasties have in recent years also shown promising results and have surpassed hip arthroplasty in frequency in western countries. However, patient satisfaction is not as high. Reported problems are insufficient function and persistent pain. On the other hand, knee arthroplasties are increasingly implanted in younger and more active patients who require high function and quality of life. Improvement of results after knee arthroplasty is therefore an urgent issue in the field of orthopaedic research.
Knee kinematics and implant designs:
A possible cause of lower function of replaced knees is the unnatural postoperative knee kinematics. The kinematics of replaced knees are closely related to their function. Studies show that replaced knees with excellent flexion angles have kinematic similarities to normal knees and malalignments of implants can cause postoperative pain.
Compared to the hip joint which is a simple ball-and-socket joint, the kinematics of knee is more complex. Native knee kinematics are a combination of a rolling and gliding motion of the femoral condyles and rotation of the tibia, where roll back of the lateral femoral condyle is larger than medially. Roll back is important for high degrees of flexion. Native knee kinematics are not fully understood, but the anterior cruciate ligament (ACL) seems to be an integral part, as knees without a functioning ACL show decreased roll back. Based on the kinematics of the normal knee joint, various attempts have been made on the design of knee implants to reconstruct normal kinematics after replacement surgery, but in knee osteoarthritis the ACL and posterior cruciate ligament (PCL) is often deficient as they are damaged by inflammation. Therefore, there are three concepts regarding the retaining of these ligaments in knee replacement surgery. 1: Sacrifice both the ACL and PCL, 2: Retain the PCL (cruciate retaining (CR) design), 3: Retain both the ACL and PCL (bicruciate-reataining design).
The function of the cruciate ligaments can be mimicked by different designs of the tibial insert. The CR design has been widely used in the northern countries, especially the Zimmer Biometri NexGen CR implant in Norway. There are migration data for the NexGen implant with high precision measurements available in the literature. However, the NexGen CR implant does not retain the ACL and does not mimic natural knee kinematics.
The tibial insert of the medially stabilized implant design (Medacta International, GMK Sphere) has a constrained medial "ball in socket" joint and at the same time allows lateral anterioposterior movement (roll back). This new design was developed by a group of dedicated researchers. The design intention is to resemble the native kinematics of the knee by mimicing the function of the cruciate ligaments and at the same time allow for lateral anterioposterior movement (rollback). Theoretically, knee implant designs, which retain the function of cruciate ligaments are predicted to have the closest kinematics to normal knees compared to other designs and to have the potential to achieve the highest patient satisfaction.
Analytical Method:
Radiostereometric Analysis (RSA) has been used in orthopedic research fields since 1970s. The original application of this method was for the evaluation of implant migration (i.e. fixation) and polyethylene wear of artificial joints using static X-ray pictures. When combining RSA with fluoroscopy, we get Fluoroscopic Roentgen Stereophotogrammetric Analysis (FRSA), a method with high accuracy and precision. Few implants have been analysed kinematically in vivo. We plan to investigate the knees during in vivo motion and weight-bearing using FRSA.
Purpose of the study:
The aim of this study is to analyse the in vivo kinematics of a medially stabilized knee arthroplasty implant (GMK Sphere) and to compare it with a well known design (Nexgen CR, Zimmer Biomet) by using FRSA.
By using flat panel fluoroscopy, we will document and compare the kinematics of the two implants in all 6 degrees of freedom (DOF).
26 patients will be randomized into two groups, one will receive the NexGen CR prosthesis, the other group the GMK Sphere.
- Conditions
- Knee Osteoarthritis
- Being tested
- Zimmer Biomet NexGen CR, Medacta International GMK Sphere
- Keywords
- Total Knee Arthroplasty (TKA), Total knee replacement (TKR), Knee kinematics, Dynamic RSA, Fluoroscopy, Fluoroscopic Roentgen Stereophotogrammetric Analysis (FRSA), Medial pivot, Medially stabilized
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Biomet NexGen CRProcedure or surgery
Total Knee Replacement
Medacta International GMK SphereProcedure or surgery
Total Knee Replacement
| Study group | Role | What they receive |
|---|---|---|
| Zimmer Biomet NexGen CR | Active comparator | Patients receive a Zimmer Biomet NexGen Total Knee Replacement Receives: Procedure: Zimmer Biomet NexGen CR |
| Medacta International GMK Sphere | Active comparator | Patients receive a Medacta International, GMK Sphere Total Knee Replacement Receives: Procedure: Medacta International GMK Sphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Kinematics measured though all Degrees of freedom (DOF)
Roentgen Fluoroscopic Stereophotogrammetric Analysis (RFSA). We measure all DOFs (i.e. X-Y-Z rotations and translations in degrees and millimeters respectively)
Measured: 1 year
Secondary outcomes (7)
Knee Society Score (KSS)
Patient Reported Outcome Measure (PROM)
Measured: 1 year
Knee injury and Osteoarthritis Outcome Score (KOOS)
PROM
Measured: 1 year
Forgotten Joint Score 12 (FJS-12)
PROM
Measured: 1 year
Range of motion (ROM)
Clinical measurement using goniometer
Measured: 1 year
Hip-knee-ankle angle (HKA-angle)
The axis of the lower extremity after knee arthroplasty
Measured: 1 year
CT-rotation of implants
Evaluation of tibia implant rotation using Berger's method
Measured: 1 year
Clinical stability
Varus-valgus stability in clinical testing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Prospective, parallel-group, non-blind, randomized clinical study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse More and Romsdal Trust
- Responsible party
- Principal investigator, Stephan M Rohrl, Oslo University Hospital
- Investigators
- Frank-David Oehrn, MD, Principal investigator, CIRRO and Kristiansund Hospital, Helse More and Romsdal TrustStephan Maximillian Røhrl, PhD, Study director, CIRRO and Oslo University Hospital, UllevålLars Harald William Engseth, MD, Principal investigator, CIRRO and Oslo University Hospital, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965690
- Sponsor's protocol ID
- 424444-2
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2016
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 17403800Kurtz SM, Lau E, Ong K, Zhao K, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct;467(10):2606-12. doi: 10.1007/s11999-009-0834-6. Epub 2009 Apr 10.
PubMed 19360453Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
PubMed 17964352Dieppe P, Lim K, Lohmander S. Who should have knee joint replacement surgery for osteoarthritis? Int J Rheum Dis. 2011 May;14(2):175-80. doi: 10.1111/j.1756-185X.2011.01611.x.
PubMed 21518317Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PubMed 22398175Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901.
PubMed 23459843Wylde V, Jeffery A, Dieppe P, Gooberman-Hill R. The assessment of persistent pain after joint replacement. Osteoarthritis Cartilage. 2012 Feb;20(2):102-5. doi: 10.1016/j.joca.2011.11.011. Epub 2011 Nov 30.
PubMed 22178464Ravi B, Croxford R, Reichmann WM, Losina E, Katz JN, Hawker GA. The changing demographics of total joint arthroplasty recipients in the United States and Ontario from 2001 to 2007. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):637-47. doi: 10.1016/j.berh.2012.07.014.
PubMed 23218428Ibrahim T, Bloch B, Esler CN, Abrams KR, Harper WM. Temporal trends in primary total hip and knee arthroplasty surgery: results from a UK regional joint register, 1991-2004. Ann R Coll Surg Engl. 2010 Apr;92(3):231-5. doi: 10.1308/003588410X12628812458572. Epub 2010 Mar 10.
PubMed 20223054Watanabe T, Ishizuki M, Muneta T, Banks SA. Knee kinematics in anterior cruciate ligament-substituting arthroplasty with or without the posterior cruciate ligament. J Arthroplasty. 2013 Apr;28(4):548-52. doi: 10.1016/j.arth.2012.06.030. Epub 2012 Oct 31.
PubMed 23122654Bell SW, Young P, Drury C, Smith J, Anthony I, Jones B, Blyth M, McLean A. Component rotational alignment in unexplained painful primary total knee arthroplasty. Knee. 2014 Jan;21(1):272-7. doi: 10.1016/j.knee.2012.09.011. Epub 2012 Nov 7.
PubMed 23140906Smith PN, Refshauge KM, Scarvell JM. Development of the concepts of knee kinematics. Arch Phys Med Rehabil. 2003 Dec;84(12):1895-902. doi: 10.1016/s0003-9993(03)00281-8.
PubMed 14669200Chalidis BE, Sachinis NP, Papadopoulos P, Petsatodis E, Christodoulou AG, Petsatodis G. Long-term results of posterior-cruciate-retaining Genesis I total knee arthroplasty. J Orthop Sci. 2011 Nov;16(6):726-31. doi: 10.1007/s00776-011-0152-1. Epub 2011 Sep 10.
PubMed 21909722Font-Rodriguez DE, Scuderi GR, Insall JN. Survivorship of cemented total knee arthroplasty. Clin Orthop Relat Res. 1997 Dec;(345):79-86.
PubMed 9418624Sabouret P, Lavoie F, Cloutier JM. Total knee replacement with retention of both cruciate ligaments: a 22-year follow-up study. Bone Joint J. 2013 Jul;95-B(7):917-22. doi: 10.1302/0301-620X.95B7.30904.
PubMed 23814243
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of in Vivo Kinematics of Different Implants in ACL-sacrificing vs. Medially Stabilized Arthroplasty (Implant Design Study)
- ClinicalTrials.gov ID
- NCT02965690
- Acronym / sponsor ID
- 424444-2
- Conditions
- Knee Osteoarthritis
- Keywords
- Total Knee Arthroplasty (TKA), Total knee replacement (TKR), Knee kinematics, Dynamic RSA, Fluoroscopy, Fluoroscopic Roentgen Stereophotogrammetric Analysis (FRSA), Medial pivot, Medially stabilized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse More and Romsdal Trust
- Study start
- Nov 2016
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.
Detailed description
Worldwide the number of patients requiring treatment for osteoarthritis is increasing due to increasing obesity, an ageing population and a high demanding younger population. Learmonth describes hip arthroplasty as the "operation of the century" because patients are highly satisfied with pain relief and function after the procedure. Knee arthroplasties have in recent years also shown promising results and have surpassed hip arthroplasty in frequency in western countries. However, patient satisfaction is not as high. Reported problems are insufficient function and persistent pain. On the other hand, knee arthroplasties are increasingly implanted in younger and more active patients who require high function and quality of life. Improvement of results after knee arthroplasty is therefore an urgent issue in the field of orthopaedic research.
Knee kinematics and implant designs:
A possible cause of lower function of replaced knees is the unnatural postoperative knee kinematics. The kinematics of replaced knees are closely related to their function. Studies show that replaced knees with excellent flexion angles have kinematic similarities to normal knees and malalignments of implants can cause postoperative pain.
Compared to the hip joint which is a simple ball-and-socket joint, the kinematics of knee is more complex. Native knee kinematics are a combination of a rolling and gliding motion of the femoral condyles and rotation of the tibia, where roll back of the lateral femoral condyle is larger than medially. Roll back is important for high degrees of flexion. Native knee kinematics are not fully understood, but the anterior cruciate ligament (ACL) seems to be an integral part, as knees without a functioning ACL show decreased roll back. Based on the kinematics of the normal knee joint, various attempts have been made on the design of knee implants to reconstruct normal kinematics after replacement surgery, but in knee osteoarthritis the ACL and posterior cruciate ligament (PCL) is often deficient as they are damaged by inflammation. Therefore, there are three concepts regarding the retaining of these ligaments in knee replacement surgery. 1: Sacrifice both the ACL and PCL, 2: Retain the PCL (cruciate retaining (CR) design), 3: Retain both the ACL and PCL (bicruciate-reataining design).
The function of the cruciate ligaments can be mimicked by different designs of the tibial insert. The CR design has been widely used in the northern countries, especially the Zimmer Biometri NexGen CR implant in Norway. There are migration data for the NexGen implant with high precision measurements available in the literature. However, the NexGen CR implant does not retain the ACL and does not mimic natural knee kinematics.
The tibial insert of the medially stabilized implant design (Medacta International, GMK Sphere) has a constrained medial "ball in socket" joint and at the same time allows lateral anterioposterior movement (roll back). This new design was developed by a group of dedicated researchers. The design intention is to resemble the native kinematics of the knee by mimicing the function of the cruciate ligaments and at the same time allow for lateral anterioposterior movement (rollback). Theoretically, knee implant designs, which retain the function of cruciate ligaments are predicted to have the closest kinematics to normal knees compared to other designs and to have the potential to achieve the highest patient satisfaction.
Analytical Method:
Radiostereometric Analysis (RSA) has been used in orthopedic research fields since 1970s. The original application of this method was for the evaluation of implant migration (i.e. fixation) and polyethylene wear of artificial joints using static X-ray pictures. When combining RSA with fluoroscopy, we get Fluoroscopic Roentgen Stereophotogrammetric Analysis (FRSA), a method with high accuracy and precision. Few implants have been analysed kinematically in vivo. We plan to investigate the knees during in vivo motion and weight-bearing using FRSA.
Purpose of the study:
The aim of this study is to analyse the in vivo kinematics of a medially stabilized knee arthroplasty implant (GMK Sphere) and to compare it with a well known design (Nexgen CR, Zimmer Biomet) by using FRSA.
By using flat panel fluoroscopy, we will document and compare the kinematics of the two implants in all 6 degrees of freedom (DOF).
26 patients will be randomized into two groups, one will receive the NexGen CR prosthesis, the other group the GMK Sphere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, parallel-group, non-blind, randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Zimmer Biomet NexGen CR | Active comparator | Procedure: Zimmer Biomet NexGen CRPatients receive a Zimmer Biomet NexGen Total Knee Replacement |
| Medacta International GMK Sphere | Active comparator | Procedure: Medacta International GMK SpherePatients receive a Medacta International, GMK Sphere Total Knee Replacement |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with knee osteoarthritis
Key exclusion criteria (13 listed)
- Preoperative severe deformity (Femoro-tibial angle < 175°or > 190° measured on a full-length leg image at weight bearing)
- Preoperative flexion contracture more than 15°
- Preoperative limited range of motion under anesthetics (less than 110°)
- Less than 50 or more than 75 years of age at the time of surgery
- Use of walking aids because of other musculoskeletal and neuromuscular problems
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 |
|---|---|---|
| Zimmer Biomet NexGen CRTotal Knee Replacement | Procedure or surgery | Zimmer Biomet NexGen CR |
| Medacta International GMK SphereTotal Knee Replacement | Procedure or surgery | Medacta International GMK Sphere |
Primary outcome
Knee Kinematics measured though all Degrees of freedom (DOF)
Time frame: 1 year
Roentgen Fluoroscopic Stereophotogrammetric Analysis (RFSA). We measure all DOFs (i.e. X-Y-Z rotations and translations in degrees and millimeters respectively)
7 secondary outcomes
Knee Society Score (KSS)
Time frame: 1 year
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 year
Forgotten Joint Score 12 (FJS-12)
Time frame: 1 year
Range of motion (ROM)
Time frame: 1 year
Hip-knee-ankle angle (HKA-angle)
Time frame: 1 year
CT-rotation of implants
Time frame: 1 year
Clinical stability
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- 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 19360453Kurtz SM, Lau E, Ong K, Zhao K, Kelly M, Bozic KJ. Future young patient demand for primary and revision joint replacement: national projections from 2010 to 2030. Clin Orthop Relat Res. 2009 Oct;467(10):2606-12. doi: 10.1007/s11999-009-0834-6. Epub 2009 Apr 10.
- Background: PubMed 17964352Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.
- Background: PubMed 21518317Dieppe P, Lim K, Lohmander S. Who should have knee joint replacement surgery for osteoarthritis? Int J Rheum Dis. 2011 May;14(2):175-80. doi: 10.1111/j.1756-185X.2011.01611.x.
- Background: PubMed 22398175Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Background: PubMed 23459843Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901.
- Background: PubMed 22178464Wylde V, Jeffery A, Dieppe P, Gooberman-Hill R. The assessment of persistent pain after joint replacement. Osteoarthritis Cartilage. 2012 Feb;20(2):102-5. doi: 10.1016/j.joca.2011.11.011. Epub 2011 Nov 30.
- Background: PubMed 23218428Ravi B, Croxford R, Reichmann WM, Losina E, Katz JN, Hawker GA. The changing demographics of total joint arthroplasty recipients in the United States and Ontario from 2001 to 2007. Best Pract Res Clin Rheumatol. 2012 Oct;26(5):637-47. doi: 10.1016/j.berh.2012.07.014.
- Background: PubMed 20223054Ibrahim T, Bloch B, Esler CN, Abrams KR, Harper WM. Temporal trends in primary total hip and knee arthroplasty surgery: results from a UK regional joint register, 1991-2004. Ann R Coll Surg Engl. 2010 Apr;92(3):231-5. doi: 10.1308/003588410X12628812458572. Epub 2010 Mar 10.
- Background: PubMed 23122654Watanabe T, Ishizuki M, Muneta T, Banks SA. Knee kinematics in anterior cruciate ligament-substituting arthroplasty with or without the posterior cruciate ligament. J Arthroplasty. 2013 Apr;28(4):548-52. doi: 10.1016/j.arth.2012.06.030. Epub 2012 Oct 31.
- Background: PubMed 23140906Bell SW, Young P, Drury C, Smith J, Anthony I, Jones B, Blyth M, McLean A. Component rotational alignment in unexplained painful primary total knee arthroplasty. Knee. 2014 Jan;21(1):272-7. doi: 10.1016/j.knee.2012.09.011. Epub 2012 Nov 7.
- Background: PubMed 14669200Smith PN, Refshauge KM, Scarvell JM. Development of the concepts of knee kinematics. Arch Phys Med Rehabil. 2003 Dec;84(12):1895-902. doi: 10.1016/s0003-9993(03)00281-8.
- 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.
Frank-David Oehrn, MD principal investigator
CIRRO and Kristiansund Hospital, Helse More and Romsdal Trust
Stephan Maximillian Røhrl, PhD study director
CIRRO and Oslo University Hospital, Ullevål
Lars Harald William Engseth, MD principal investigator
CIRRO and Oslo University Hospital, Ullevål
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zimmer Biomet NexGen CR and Medacta International GMK Sphere in people with Knee Osteoarthritis, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 13 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 6 Feb 2024. 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 Norway. 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?
Knee Kinematics measured though all Degrees of freedom (DOF) (time frame: 1 year). 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 NCT02965690, which also lists 27 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 6 Feb 2024.