Gonarthrosis; PrimaryNCT03059927
The Effect of Three Prosthesis Designs in Total Knee Arthroplasty
A study testing Knee arthroplasty, Cruciate retaining, Knee arthroplasty, Anterior stabilized and Knee arthroplasty, Posterior stabilized in people with Gonarthrosis; Primary and Degenerative Joint Disease of Knee, run by Lovisenberg Diakonale Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Gonarthrosis; Primary, Degenerative Joint Disease of Knee
- What is being tested?
- Knee arthroplasty, Cruciate retaining, Knee arthroplasty, Anterior stabilized and Knee arthroplasty, Posterior stabilized
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Mar 2017to 31 Dec 2023
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior ACL (anterior cruciate ligament) surgery
- Impaired collateral ligaments
- Secondary osteoarthritis of the knee
- Previous osteotomy
- Rheumatic disease
- Flexion less than 90 degrees
Show all 10Show fewer
- Flexion contracture over 10 degrees
- Peripheral neuropathy
- Malignancy
- Patients who do not speak Norwegian
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Not yet recruiting
Haugesund Rheumatism Hospital
Haugesund, 5528
Øystein Gøthesen, Md, PhD, 988 08162
- Recruiting
Lovisenberg Diaconal Hospital
Oslo, 0446
Arild Aamodt, MD, PhD, aara@lds.no
Yasser Rehman, MD
About this study
Official title: The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
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.
Read the 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.
- Being tested
- Knee arthroplasty, Cruciate retaining, Knee arthroplasty, Anterior stabilized, Knee arthroplasty, Posterior stabilized
- Keywords
- Cruciate retaining, Anterior stabilized, Posterior stabilized, Posterior cruciate ligament, Degenerative knee joint disease, Knee injury and Osteoarthritis Outcome Score, Kinematic radiostereometry
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee arthroplasty, Cruciate retainingProcedure or surgery
Legion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design
Knee arthroplasty, Anterior stabilizedProcedure or surgery
Legion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design
Knee arthroplasty, Posterior stabilizedProcedure or surgery
Legion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design
| Study group | Role | What they receive |
|---|---|---|
| Knee arthroplasty, Cruciate retaining | Active comparator | Total knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert. Receives: Procedure: Knee arthroplasty, Cruciate retaining |
| Knee arthroplasty, Anterior stabilized | Active comparator | Total knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert. Receives: Procedure: Knee arthroplasty, Anterior stabilized |
| Knee arthroplasty, Posterior stabilized | Active comparator | Total knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design. Receives: Procedure: Knee arthroplasty, Posterior stabilized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative, 1, 2 and 5 years
Secondary outcomes (6)
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.
Measured: Pre-operative, 1, 2 and 5 years
EQ-5D-5L
EQ-5D-5L is a widely-used patient-administered instrument for describing health-related quality of life
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonarthrosis; PrimaryStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haugesund Rheumatism Hospital
- Responsible party
- Sponsor
- Investigators
- Arild Aamodt, MD, PhD, Study director, Lovisenberg Diaconal Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059927
- Sponsor's protocol ID
- LovisenbergOrto
- Status last verified
- Feb 2017
- First submitted
- 16 Feb 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Prosthesis Designs on Implant Stability and Survival, Knee Function, and Clinical Course in Knee Arthroplasty: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03059927
- Acronym / sponsor ID
- LovisenbergOrto
- Keywords
- Cruciate retaining, Anterior stabilized, Posterior stabilized, Posterior cruciate ligament, Degenerative knee joint disease, Knee injury and Osteoarthritis Outcome Score, Kinematic radiostereometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- Haugesund Rheumatism Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee arthroplasty, Cruciate retaining | Active comparator | Procedure: Knee arthroplasty, Cruciate retainingTotal knee replacement with preserved posterior cruciate ligament and a cruciate retaining insert. |
| Knee arthroplasty, Anterior stabilized | Active comparator | Procedure: Knee arthroplasty, Anterior stabilizedTotal knee replacement with sacrificed posterior cruciate ligament and an anterior stabilized insert. |
| Knee arthroplasty, Posterior stabilized | Active comparator | Procedure: Knee arthroplasty, Posterior stabilizedTotal knee replacement with sacrificed posterior cruciate ligament and a posterior stabilized design. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Prior ACL (anterior cruciate ligament) surgery
- Impaired collateral ligaments
- Secondary osteoarthritis of the knee
- Previous osteotomy
- Rheumatic disease
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 |
|---|---|---|
| Knee arthroplasty, Cruciate retainingLegion total knee arthroplasty implant component, Smith \& Nephew, Cruciate Retaining design | Procedure or surgery | Knee arthroplasty, Cruciate retaining |
| Knee arthroplasty, Anterior stabilizedLegion total knee arthroplasty implant component, Smith \& Nephew, Anterior Stabilized design | Procedure or surgery | Knee arthroplasty, Anterior stabilized |
| Knee arthroplasty, Posterior stabilizedLegion total knee arthroplasty implant component, Smith \& Nephew, Posterior Stabilized design | Procedure or surgery | Knee arthroplasty, Posterior stabilized |
Primary outcome
Knee injury and osteoarthritis outcome score (KOOS)
Time frame: Pre-operative, 1, 2 and 5 years
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.
6 secondary outcomes
Oxford knee score (OKS)
Time frame: Pre-operative, 1, 2 and 5 years
EQ-5D-5L
Time frame: Pre-operative, 1, 2 and 5 years
Range of motion (ROM)
Time frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Kinematic radiostereometric analysis (RSA)
Time frame: After 12 months
Plain anterior posterior radiographs and hip, knee and ankle (HKA) radiographs
Time frame: Pre-operative, 3, 12, 24 and 60 months
Brief Pain Inventory
Time frame: Pre-operative, 6 weeks, 3, 12, 24 and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- 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.
Arild Aamodt, MD, PhD study director
Lovisenberg Diaconal Hospital, Oslo, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee arthroplasty, Cruciate retaining, Knee arthroplasty, Anterior stabilized and Knee arthroplasty, Posterior stabilized in people with Gonarthrosis; Primary and Degenerative Joint Disease of Knee, run by Lovisenberg Diakonale Hospital at 2 sites 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 7 inclusion and 10 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 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Yasser Rehman, MD (+4798477583, yare@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee injury and osteoarthritis outcome score (KOOS) (time frame: Pre-operative, 1, 2 and 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.