Osteoarthritis Clinical Trial
— Attune-RSAOfficial title:
Anatomo-functional Correlation Between Intra-operative Passive Kinematics Recorded by Navigation and Post-operative Kinematics Analyzed by Dynamic Weight Bearing RSA of the Operated Knee.
NCT number | NCT02323386 |
Other study ID # | 46/13 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | September 2016 |
Verified date | May 2018 |
Source | Istituto Ortopedico Rizzoli |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per
year. Statistics indicate that for patients over 60 year old approximately one out of 20 will
require corrective reoperations within 10 years after surgery. However, for patients younger
than 60 years, approximately one out of 10 will require revision total knee arthroplasty
within 10 years of surgery. As the number of younger patients is increasing, there has been a
shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and
implant longevity being the important issues for quality of patient care. Furthermore, it has
been reported that up to 25% of patients are not satisfied with the functional results of
their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However
these are often static, because of even most advanced x-ray film exchanger limit the number
of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real
time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction.
The purpose of this study is to investigate the effect of a new implant design on the
post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A
prospective randomized study will be performed on a new implant: the DePuy ATTUNETM
fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.
Status | Completed |
Enrollment | 20 |
Est. completion date | September 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Severe radiographic osteoarthritis (Kellgren-Lawrence grade >3) - Patients scheduled for a primary TKA - Willing to take part in study and providing HIPAA authorization Exclusion Criteria: - Previous corrective osteotomy on the affected lower limb - Post-traumatic arthritis - Severe preoperative valgus deformity (Hip Knee Ankle angle>10°) - BMI>40 kg/m2 - Rheumatoid arthritis - Chronic inflammatory joint diseases - Patients with a pre-pathological abnormal gait (amputated, neuromuscular disorders, poliomyelitis, developmental dysplasia of the hip) - Severe ankle osteoarthritis (Kellgren-Lawrence>3) - Severe hip osteoarthritis (Kellgren-Lawrence>3) - Previous total hip or ankle replacement - Unwilling to take part in study and providing HIPAA authorization |
Country | Name | City | State |
---|---|---|---|
Italy | Rizzoli Orthopaedic Institute | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli | DePuy International |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking. | The joint kinematic was acquired using the dynamic RSA technique. The rotations (angular degree) and translations (millimeter) were evaluated using the Euler decomposition and the Low-point algorithm. | 9 months | |
Secondary | Correlation of clinical reported results (KSS, Oxford, SF36, WOMAC) and patients' subjective satisfaction using a visual analogue scale (VAS) with kinematics differences and ground reaction forces. | KSS, OXFORD, SF36, WOMAC, VAS scores will be assessed and recorded pre-operatively and post operatively at 6 months after surgery | 9 months | |
Secondary | Quantification the ground reaction forces during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking. | Forces (newton N) | 9 months |
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