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The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

Primary Purpose

Gonarthrosis; Primary, Degenerative Joint Disease of Knee

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Knee arthroplasty, Cruciate retaining
Knee arthroplasty, Anterior stabilized
Knee arthroplasty, Posterior stabilized
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gonarthrosis; Primary focused on measuring Cruciate retaining, Anterior stabilized, Posterior stabilized, Posterior cruciate ligament, Degenerative knee joint disease, Knee injury and Osteoarthritis Outcome Score, Kinematic radiostereometry

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary osteoarthritis
  • Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs
  • Intact PCL (assessed preoperatively and verified during surgery)
  • Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA)
  • Body mass index ≤ 35 kg/m2
  • ASA (American Society of Anaesthesiologists) score I or II
  • Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis

Exclusion Criteria:

  • Prior ACL (anterior cruciate ligament) surgery
  • Impaired collateral ligaments
  • Secondary osteoarthritis of the knee
  • Previous osteotomy
  • Rheumatic disease
  • Flexion less than 90 degrees
  • Flexion contracture over 10 degrees
  • Peripheral neuropathy
  • Malignancy
  • Patients who do not speak Norwegian

Sites / Locations

  • Haugesund Rheumatism Hospital
  • Lovisenberg Diaconal HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Knee arthroplasty, Cruciate retaining

Knee arthroplasty, Anterior stabilized

Knee arthroplasty, Posterior stabilized

Arm Description

Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.

Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.

Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
EQ-5D-5L
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
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
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.
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
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.

Full Information

First Posted
February 16, 2017
Last Updated
April 19, 2017
Sponsor
Lovisenberg Diakonale Hospital
Collaborators
Haugesund Rheumatism Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03059927
Brief Title
The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
Official Title
The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lovisenberg Diakonale Hospital
Collaborators
Haugesund Rheumatism Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gonarthrosis; Primary, Degenerative Joint Disease of Knee
Keywords
Cruciate retaining, Anterior stabilized, Posterior stabilized, Posterior cruciate ligament, Degenerative knee joint disease, Knee injury and Osteoarthritis Outcome Score, Kinematic radiostereometry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Knee arthroplasty, Cruciate retaining
Arm Type
Active Comparator
Arm Description
Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert.
Arm Title
Knee arthroplasty, Anterior stabilized
Arm Type
Active Comparator
Arm Description
Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert.
Arm Title
Knee arthroplasty, Posterior stabilized
Arm Type
Active Comparator
Arm Description
Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design.
Intervention Type
Procedure
Intervention Name(s)
Knee arthroplasty, Cruciate retaining
Intervention Description
Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
Intervention Type
Procedure
Intervention Name(s)
Knee arthroplasty, Anterior stabilized
Intervention Description
Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
Intervention Type
Procedure
Intervention Name(s)
Knee arthroplasty, Posterior stabilized
Intervention Description
Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design
Primary Outcome Measure Information:
Title
Knee injury and osteoarthritis outcome score (KOOS)
Description
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.
Time Frame
Pre-operative, 1, 2 and 5 years
Secondary Outcome Measure Information:
Title
Oxford knee score (OKS)
Description
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.
Time Frame
Pre-operative, 1, 2 and 5 years
Title
EQ-5D-5L
Description
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
Time Frame
Pre-operative, 1, 2 and 5 years
Title
Range of motion (ROM)
Description
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
Time Frame
Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Title
Kinematic radiostereometric analysis (RSA)
Description
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.
Time Frame
After 12 months
Title
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Description
Radiographs obtained for assessment of fixation of the prosthesis and the alignment.
Time Frame
Pre-operative, 3, 12, 24 and 60 months
Title
Brief Pain Inventory
Description
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.
Time Frame
Pre-operative, 6 weeks, 3, 12, 24 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary osteoarthritis Non-fixed or fixed varus or valgus deformity less than 15º measured on preoperative standing hip-knee-ankle (HKA) radiographs Intact PCL (assessed preoperatively and verified during surgery) Age 45 - 75 years (only patients 45 - 70 years will be included in the kinematic RSA) Body mass index ≤ 35 kg/m2 ASA (American Society of Anaesthesiologists) score I or II Only patients with KOOS scores above 80 on the Symptoms, ADL (Activities of Daily Living) and Pain subscales will be included in the kinematic analysis Exclusion Criteria: Prior ACL (anterior cruciate ligament) surgery Impaired collateral ligaments Secondary osteoarthritis of the knee Previous osteotomy Rheumatic disease Flexion less than 90 degrees Flexion contracture over 10 degrees Peripheral neuropathy Malignancy Patients who do not speak Norwegian
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasser Rehman, MD
Phone
+4798477583
Email
yare@lds.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arild Aamodt, MD, PhD
Organizational Affiliation
Lovisenberg Diaconal Hospital, Oslo, Norway
Official's Role
Study Director
Facility Information:
Facility Name
Haugesund Rheumatism Hospital
City
Haugesund
ZIP/Postal Code
5528
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Øystein Gøthesen, Md, PhD
Phone
988 08162
Facility Name
Lovisenberg Diaconal Hospital
City
Oslo
ZIP/Postal Code
0446
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arild Aamodt, MD, PhD
Email
aara@lds.no
First Name & Middle Initial & Last Name & Degree
Yasser Rehman, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Three Prosthesis Designs in Total Knee Arthroplasty

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