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

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 - Rotation stability after preservation of the ACL in TKA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48002

Enrollment

Registered

2020-02-10

Start date

2020-08-25

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament movement analysis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rotational degrees of freedom of the tibial implant, measured with 3-D motion analysis after operation and compared between the XP tibia implant and CR conventional tibia implant	—

Secondary

Measure	Time frame
Comparing operative, clinical and radiological outcome of either the XP tibia implant compared to the standard CR tibia implant. standard intramedullary alignment guides.	—

Countries

Netherlands

Outcome results