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A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated.
The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability.
The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System.
This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persona CR | Active Comparator | Patients who received a Persona CR total knee implant |
|
| NexGen CR | Active Comparator | Patients who received a NexGen CR total knee implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Persona total knee system | Device | 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score | The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27 | 3 months, 1 year and 2 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score - Activity & Participation Questionnaire (APQ) | The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score). | 3 months, 1 year and 2 years postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Troelsen, Professor | Hvidovre University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Orthopaedic Surgery, Farsø Sygehus, Ålborg Universitetshospital | Aalborg | DK-9000 | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39998994 | Derived | Mortensen KRL, Ingelsrud LH, Odgaard A, Kappel A, Varnum C, Schroder H, Gromov K, Troelsen A. Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial. Acta Orthop. 2025 Feb 25;96:195-202. doi: 10.2340/17453674.2025.43004. |
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18 patients not assigned to any group: 5 rescinded consent before surgery, 13 recorded as lost to follow-up for other reasons
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| ID | Title | Description |
|---|---|---|
| FG000 | Persona CR | Patients who received a Persona CR total knee implant |
| FG001 | NexGen CR | Patients who received a NexGen CR total knee implant |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Persona CR | Patients who received a Persona CR total knee implant |
| BG001 | NexGen CR | Patients who received a NexGen CR total knee implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oxford Knee Score | The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27 | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | 3 months, 1 year and 2 years postoperatively |
|
From study start up to 2 years post-operatively
Adverse events have been documented continuously by checking with the study patients at every follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Persona CR | Patients who received a Persona CR total knee implant, excluding the 1 case excluded intraoperatively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer Diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chiara Griffoni, Clinical Project Senior Lead | Zimmer Biomet | +41 79 560 16 28 | chiara.griffoni@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2016 | Jul 26, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Nexgen total knee system | Device | 314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen |
|
|
| Forgotten Joint Score (FJS) | The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of the joint during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of joint awareness, while a total score of 0 indicates the highest level of joint awareness. | 3 months, 1 year and 2 years postoperatively |
| Patient Satisfaction and Anchoring Questions - Question 1 | Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?" | 3 months, 1 year and 2 years postoperatively |
| Patient Satisfaction and Anchoring Questions - Question 2 | Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?" | 3 months, 1 year and 2 years postoperatively |
| Patient Satisfaction and Anchoring Questions - Question 3 | Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?" | 3 months, 1 year and 2 years postoperatively |
| Patient Satisfaction and Anchoring Questions - Question 4 | Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?" | 3 months, 1 year and 2 years postoperatively |
| EuroQol 5D (EQ-5D) Score | The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead. | 3 months, 1 year and 2 years postoperatively |
| Radiolucency / Osteolysis | All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately. | Immediate postoperative and 3 months, 1 year and 2 years postoperatively |
| Long-term Survivorship | Registry data at 5, 7 and 10 years postoperatively. | 5, 7 and 10 years postoperatively. |
| Copenhagen University hospital, Gentofte |
| Copenhagen |
| DK-2900 |
| Denmark |
| Hvidovre hospital | Copenhagen | Denmark |
| Dept. of Orthopaedic Surgery, Næstved Sygehus | Næstved | DK-4700 | Denmark |
| Dept. of Orthopaedic Surgery, Vejle Sygehus, Sygehus Lillebælt | Vejle | DK-7100, | Denmark |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Adverse Event |
|
| Met an exclusion criterion |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients who received a Persona CR total knee implant
| OG001 | NexGen CR | Patients who received a NexGen CR total knee implant |
|
|
|
| Secondary | Oxford Knee Score - Activity & Participation Questionnaire (APQ) | The OKS-APQ is an 8 item questionnaire with each question scored from 0 (worst outcome) to 4 (best outcome). The resulting score is then summed and converted to a score ranging from 0 (worst possible score) to a maximum of 100 (best possible score). | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Forgotten Joint Score (FJS) | The FJS-12 is a patient-reported outcome questionnaire that was developed to specifically assess the patient's level of awareness of the joint during daily activities. The FJS consists of twelve questions covering function and pain associated with the knee. For each question, there is a choice of five answers between never (0), almost never (1), seldom (2), sometimes (3) and mostly (4). All scores are summed up and divided by the number of completed items. This value is then multiplied by 25 and thereafter subtracted from 100. An outcome score of 100 (highest possible score) indicates the lowest level of joint awareness, while a total score of 0 indicates the highest level of joint awareness. | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Error | score on a scale | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Patient Satisfaction and Anchoring Questions - Question 1 | Patients were asked to answer the following satisfaction/anchoring question: "How are your knee problems now, compared to prior to your operation?" | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Patient Satisfaction and Anchoring Questions - Question 2 | Patients were asked to answer the following satisfaction/anchoring question: "Taking into account all the activities you have during your daily life, your level of pain and functional impairment, do you consider that your current state is satisfactory?" | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Patient Satisfaction and Anchoring Questions - Question 3 | Patients were asked to answer the following satisfaction/anchoring question: "If you answered No, i.e. not satisfied to the result would you consider your current state as being so unsatisfactory that you think the treatment has failed?" | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Patient Satisfaction and Anchoring Questions - Question 4 | Patients were asked to answer the following satisfaction/anchoring question: "Would you have your knee operated again?" | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | EuroQol 5D (EQ-5D) Score | The EQ-5D is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self-care, daily/usual activities, pain/discomfort and anxiety/depression. For EQ-5D-3L, each question can be answered in three ways, indicating no, moderate, or extreme pain. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.59; negative numbers correspond to a self-assessed health state worse than being dead. | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Mean | Standard Deviation | score on a scale | 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Radiolucency / Osteolysis | All X-rays were sent to an independent radiographer. Postoperative lucency was determined as presence of radiolucent intervals at the cement-bone interface. Femoral lucency and tibial lucency are reported separately. | 157 patients were enrolled and randomized to each group, but 3 cases were excluded intraoperatively: 2 in the NexGen group and 1 in the Persona group. Additionally, some data points are missing due to missed follow-up visits or incomplete form completion | Posted | Count of Participants | Participants | Immediate postoperative and 3 months, 1 year and 2 years postoperatively |
|
|
|
| Secondary | Long-term Survivorship | Registry data at 5, 7 and 10 years postoperatively. | Not Posted | Dec 2031 | 5, 7 and 10 years postoperatively. | Participants |
| 1 |
| 156 |
| 23 |
| 156 |
| 16 |
| 156 |
| EG001 | NexGen CR | Patients who received a NexGen CR total knee implant, excluding the 2 cases excluded intraoperatively. | 0 | 155 | 28 | 155 | 20 | 155 |
| Congestive Hearth Failure | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
|
| Pancreatitis | Endocrine disorders | Systematic Assessment |
|
| Infection (non-knee) | Gastrointestinal disorders | Systematic Assessment |
|
| Gallstone + Pancreatitis | Hepatobiliary disorders | Systematic Assessment |
|
| Shoulder Fracture Due to Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shoulder Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Pain Due to Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Patella Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Patella Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Trochanteric Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Nerve Injury | Nervous system disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of Breath/Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Bowel Rupture | Surgical and medical procedures | Systematic Assessment |
|
| Contralateral Knee Replacement | Surgical and medical procedures | Systematic Assessment |
|
| Foot Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Gastric Bypass | Surgical and medical procedures | Systematic Assessment |
|
| Hip Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Spinal Stenosis | Surgical and medical procedures | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
|
| Cerebral Aneurysma | Nervous system disorders | Systematic Assessment |
|
| Hypoglycemia + Influenza | Infections and infestations | Systematic Assessment |
|
| Revision Contralateral Knee | Surgical and medical procedures | Systematic Assessment |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tibial Base Plate Loosening | Surgical and medical procedures | Systematic Assessment | Revision surgery performed, all components revised |
|
| Infection (knee) | Surgical and medical procedures | Systematic Assessment | Revision surgery performed, all components revised |
|
| Dislocated Liner | Surgical and medical procedures | Systematic Assessment | Revision surgery performed, only liner revised |
|
| Knee Instability | Surgical and medical procedures | Systematic Assessment | Revision surgery performed, only liner revised |
|
| Flexion Contracture | Surgical and medical procedures | Systematic Assessment | Revision surgery performed, all components revised |
|
| Contralateral Knee Replacement | Surgical and medical procedures | Systematic Assessment | Planned hospitalization for a pre-existing condition (bilateral osteoarthritis) |
|
| Delayed Wound Healing | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Effusion | Blood and lymphatic system disorders | Systematic Assessment | No hospitalization required |
|
| Flexion Contracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | No hospitalization required |
|
| Knee Pain Due to Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment | No hospitalization required |
|
| Knee Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee Stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment | No hospitalization required |
|
Not provided
| D012216 |
| Rheumatic Diseases |
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| Somewhat better, but enough to be an important improvement |
|
| Very small change, not enough to be an important improvement |
|
| About the same |
|
| Very small change, not enough to be an important worsening |
|
| Somewhat worse, but enough to be an important worsening |
|
| Worse, an important worsening |
|
| Better, an important improvement + About the same |
|
| Very small change,not enough to be an important worsening + Somewhat worse |
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| 1 year |
|
|
| 2 years |
|
|
| No |
|
| No answer provided |
|
| 1 year |
|
|
| 2 years |
|
|
| Maybe, don't know |
|
| No |
|
| 1 year |
|
|
| 2 years |
|
|
| 3 months |
|
|
| 1 year |
|
|
| 2 years |
|
|
| Immediate postoperative : Femoral lucency |
|
|
| 3 months : Tibial lucency |
|
|
| 3 months : Femoral lucency |
|
|
| 1 year : Tibial lucency |
|
|
| 1 year : Femoral lucency |
|
|
| 2 years : Tibial lucency |
|
|
| 2 years : Femoral lucency |
|
|