Primary objective:Is there a significant difference in Anterior/Posterior stability between MRK, LCS and NexGen total knee prosthesis 1 year post-op?Secondary objectives:Is there a relevant correlation between Anterior/Posterior stability and…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint:
Measurement with Kneelax device will provide comparison in anterior/posterior
displacement (laxity) of the replaced joint at 30, 60 and 90 degrees angle.
With these measurements the three prosthesis will be compared. This measurement
will take place once: 12 months post-op. Kneelax is a validated device for
measuring such displacement. Measurement will take place in hospital under
supervision of a trained physical therapist.
A difference of 2 mm A/P stability is determined as relevant.
Secondary outcome
Secondary study parameters/endpoints
Satisfaction and patient outcome scores (PROMS) and functional scores will be
assessed pre-operatively, and post-operatively at 12 months and at 2 years
(optional) by questionnaires. This will be assessed using following methods;
PRE-OP:
* Visual Analogue Scale (VAS) for pain at rest and during activity. Note:
validated test
* Visual Analogue Scale (VAS) for stability.
* EQ-5D . Note: validated test
* Knee Injury and Orthoarthritis Score (KOOS). Note: validated test
* Oxford Knee score. Note: validated test
* Knee Society Clinical Rating System (KSCRS). Note: validated test
* Kujala Anterior Knee Pain Score. Note: validated test
POST-OP:
* Visual Analogue Scale (VAS) for pain at rest and during activity. Note:
validated test
* Visual Analogue Scale (VAS) for stability
* EQ-5D. Note: validated test
* Knee Injury and Orthoarthritis Score (KOOS). Note: validated test
* Oxford Knee score. Note: validated test
* Satisfaction score; *would you do it again? (VAS). Note: validated test
* Knee Society Clinical Rating System (KSCRS). Note: validated test
* Kujala Anterior Knee Pain Score. Note: validated test
Background summary
This study aims to distinguish relevant differences between three well
established types of prosthesis regarding anterior/posterior stability; Medial
Rotation Knee, MRK (Matortho, UK), LCS (Depuy, UK, USA) and Nexgen (Zimmer,
USA). Data derived from the study will give new insight in relevant different
behaviour of prosthesis mentioned above and will lead to better understanding
of improving patient satisfaction in total knee arthroplasty.
Study objective
Primary objective:
Is there a significant difference in Anterior/Posterior stability between MRK,
LCS and NexGen total knee prosthesis 1 year post-op?
Secondary objectives:
Is there a relevant correlation between Anterior/Posterior stability and
Patient Outcome?
Is there a difference regarding Patient Outcome between MRK and LCS or NexGen
total knee prosthesis?
Study design
General
This study is a blind randomised, multi-centre clinical study. The study will
include three centres and five surgeons. Each centre will recruit a minimum of
100 patients over a period of maximum 18 months. Each patient will be
randomised to receive either:
* MRK or LCS (2 centres)
* MRK or Nexgen (1 centre)
Total cohort of patients will therefore exceed 300 implants. All surgeons will
implant relevant amount of the type of prosthesis involved before including
data into the study to overcome effect of bias due to *learning curve*. At
present time (before start study) all hospitals are already experienced with
the prosthesis involved.
Length of Study
Individual study patients will be seen for at least 2 years after surgery. The
enrolment period is expected to be 1 to 2 years or until the required sample
size is reached. Measurements to encounter the primary objective will be
conducted 1 year post-op.
Patient Selection Criteria
In general the patients for the study will be selected out of those who are
eligible for total knee replacement due to arthrosis of the knee joint. The
Investigator is responsible for evaluating each patient against applicable
criteria and assuring that the patient meets the requirements to be enrolled in
this clinical investigation. Each patient enrolled in this investigation must
meet inclusion criteria and have none of the exclusion criteria.
Intervention
Patients who are included in study will receive a total knee replacement which
they were about to receive anyway. Standard surgical procedure and rehab
programme will be followed which is not influenced by the study. The
measurement 1 year post-op with the Kneelax device is non-invasive and will be
conducted by involved and trained physiotherapists. Additional strain on the
joint when measured is carefully controlled and side effects are not expected
in any way. All other tests and research consists of questionnaires which be
asked to perform on routine visits of patients to the clinical sites.
Intervention is therefore only present regarding the process of randomization.
Study burden and risks
No additional risks are associated with participation in the study. Patients
who are included in study will receive a total knee replacement which they were
about to receive anyway. Standard surgical procedure and rehab programme will
be followed which is not influenced by the study. The measurement 1 year
post-op with the Kneelax device is non-invasive and will be conducted by
involved and trained physiotherapists. Additional strain on the joint when
measured is carefully controlled and side effects are not expected in any way.
All other tests and research consists of questionnaires which be asked to
perform on routine visits of patients to the clinical sites.
Bolswarderbaan 1
Sneek 8601 ZK
NL
Bolswarderbaan 1
Sneek 8601 ZK
NL
Listed location countries
Age
Inclusion criteria
* Patients requiring a knee replacement as determined jointly by the surgeon and the patient
* Over 18 years of age at time of surgery
* Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
* Patients who are capable of, and have given, informed consent to their participation in the study
Exclusion criteria
* Patients lacking capacity to or who will not provide consent
* Severe muscular, neurological or vascular deficiencies which compromise the affected extremity
* Bone deficiency or deficient bone quality likely to compromise the implant (as determined by surgical team on pre-operative radiographs)
* Severe ligament instability
* Hypersensitivity to the materials used
* Alcoholism or other addictive disorders
* Sepsis
* Osteomyelitis
* Osteomalacia
* Severe Osteoporosis * clinical judgement
* Metabolic disorders which may impair bone formation
* Non correctable flexion contractures >20 degrees
* Varus/valgus deformities >15 degrees
* Those whose prospects for a recovery to independent mobility would be compromised by known pre-existing medical conditions
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52316.044.15 |
| Other | volgt nog |