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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
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41915
Enrollment
68
Registered
2015-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

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

Sponsors

Orbis Medisch Centrum
Lead Sponsor

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

MeasureTime 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 operated with either the MRI-based Signature* guide or the Conventional alignment

Secondary

MeasureTime frame
Comparing operative, clinical and radiological outcome of the operative procedure with Signature* and/or the conventional standard intramedullary alignment guides.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)