Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Haugesund Rheumatism Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare three prosthesis designs to compare three prosthesis designs for total knee arthroplasty and determine the best option for patients in need of a knee replacement.
Total knee arthroplasty (TKA) is a cost beneficial surgery shown to improve pain, function and quality of life in patients with osteoarthritis. In 2015, 6093 patients received primary TKA in Norway. Despite the procedure´s general success, 20% of patients report persistent postoperative pain and/or dissatisfaction with the surgical outcome. Efforts to further improve the procedure have raised considerable debate regarding the role and management of the posterior cruciate ligament (PCL). Prostheses for TKA have evolved into designs that either preserve or sacrifice the PCL. In patients with a functional PCL, the decision of which design is selected depends largely on the favor and training of the surgeon. To further improve TKA patient outcomes, a better understanding of the role of these differing PCL treatments is needed. Thus, the aim of this study is to determine whether patients' perceived outcome, implant stability and clinical outcome differ between 3 TKA implant designs (2 PCL-sacrificing and 1 PCL-retaining). We will conduct a 3-arm randomized controlled prospective trial with 5-year follow-up. This study will have impact on clinical practice by addressing the lack of evidence supporting use of these different types of implants.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Knee arthroplasty, Cruciate retaining | Active Comparator | Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert. |
|
| Knee arthroplasty, Anterior stabilized | Active Comparator | Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert. |
|
| Knee arthroplasty, Posterior stabilized | Active Comparator | Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee arthroplasty, Cruciate retaining | Procedure | Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and osteoarthritis outcome score (KOOS) | KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. | Pre-operative, 1, 2 and 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford knee score (OKS) | OKS is a brief patient-completed questionnaire for patients undergoing total knee arthroplasty. It reflects the patient's assessment of their knee-related health status and benefits of treatment. | Pre-operative, 1, 2 and 5 years |
| EQ-5D-5L |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasser Rehman, MD | Contact | +4798477583 | yare@lds.no |
| Name | Affiliation | Role |
|---|---|---|
| Arild Aamodt, MD, PhD | Lovisenberg Diaconal Hospital, Oslo, Norway | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haugesund Rheumatism Hospital | Not yet recruiting | Haugesund | 5528 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Knee arthroplasty, Anterior stabilized | Procedure | Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design |
|
| Knee arthroplasty, Posterior stabilized | Procedure | Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design |
|
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life |
| Pre-operative, 1, 2 and 5 years |
| Range of motion (ROM) | ROM will be measured by extension and flexion with a goniometer preoperatively at baseline and at each follow-up visit (6 weeks, 3 months, 12 months, 24 months and 60 months | Pre-operative, 6 weeks, 3, 12, 24 and 60 months |
| Kinematic radiostereometric analysis (RSA) | Knee motion while walking up and down stairs, and during squatting and kneeling activities will be recorded using video fluoroscopy (dynamic RSA) at 12 months. | After 12 months |
| Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs | Radiographs obtained for assessment of fixation of the prosthesis and the alignment. | Pre-operative, 3, 12, 24 and 60 months |
| Brief Pain Inventory | We will use three single items to measure worst pain intensity, average pain intensity, and pain interference with walking. Patients rate their pain intensity and pain interference with walking on an 11-point numeric rating scale from 0-10, where 0=no pain/no interference and 10=worst imaginable pain/complete interference. | Pre-operative, 6 weeks, 3, 12, 24 and 60 months |
| Lovisenberg Diaconal Hospital | Recruiting | Oslo | 0446 | Norway |
|
| D012216 |
| Rheumatic Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |