Preservation of both cruciate ligaments as essential step to the forgotten knee. Do we need the anterior cruciate ligament for better functional outcomes? A randomized controlled gait analysis trial
- Conditions
- Anterior Cruciate Ligamentmovement analysis10023213
- Registration Number
- NL-OMON41915
- Lead Sponsor
- Orbis Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 68
•Indicated for a TKA
•Patients with pre-existing contra lateral knee surgery
•Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
•Correction of varus, valgus, or posttraumatic deformity
•Sufficient soft tissue surrounding the knee, including the ACL and PCL
•High need to obtain pain relief and improve function
•Body-mass-index (BMI) <35
•Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
•Consent form read, understood and signed by patient.
•BMI =>35
•Use of Anterior Stabilized Bearings or Posterior Stabilized Bearings
•Patients with severe pre-operative varus or valgus deformity =>15 degrees
•Correction or revision of previous joint replacement procedure on index knee
•Sepsis
•Osteomyelitis
•Active infection in knee
•General infection
•Distant foci of infections which may spread to the implant site
•Failure of previous joint replacement
•Pregnancy
•Previous major knee surgery, except for arthroscopic meniscectomy.
•Metal near knee joint (MRI-scan not possible)
•Rheumatoid arthritis
•Extension deficit >15 degrees
•Flexion <100 degrees.
•Non-correctable varus axis
•Cruciate ligament insufficiency
•Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
•Uncooperative patient or patient with neurological disorders who is incapable of following directions
• Osteoporosis, metabolic disorders and osteomalacia on the basis of the X-ray which is evaluated by the orthopedic surgeon
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rotational degrees of freedom of the tibial implant, measured with 3-D motion<br /><br>analysis after operation and compared between the XP tibia implant and CR<br /><br>conventional tibia implant operated with either the MRI-based Signature* guide<br /><br>or the Conventional alignment </p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparing operative, clinical and radiological outcome of the operative<br /><br>procedure with Signature* and/or the conventional standard intramedullary<br /><br>alignment guides.</p><br>