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

Recruiting

• Conditions: movement analysis; Anterior Cruciate Ligament; 10023213

• Registration Number: NL-OMON48002
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 64

Inclusion Criteria

•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 followup
evaluations.
•Consent form read, understood and signed by patient.

Exclusion Criteria

•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<br /><br>between the XP tibia implant and CR conventional tibia implant</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparing operative, clinical and radiological outcome of either the XP tibia<br /><br>implant compared to the<br /><br>standard CR tibia implant.<br /><br>standard intramedullary alignment guides.</p><br>