Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA (rKA-KA-TKA)

Assiut University

Status: Not yet enrolling

Conditions: Total Knee Anthroplasty; Osteoarthritis (OA) of the Knee

Treatments: Procedure: Total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06726993

04-2024-100320

Details and patient eligibility

About

Knee osteoarthritis is a growing socioeconomic burden because of the ageing and obesity. By 2030, the majority of individuals undergoing knee arthroplasty in USA will be those younger than 65 years, with up to 1 million achieved annually.

The definitive treatment for knee joint degeneration is total knee arthroplasty.

Full description

Furthermore, the commonest technique is neutral mechanical alignment total knee arthroplasty. Latest studies have revealed that the mechanical alignment technique repeatedly causing substantial anatomical alterations with a widespread of complex collateral ligament imbalances, which are not repairable by collateral ligament release. Consequently, the total knee arthroplasty individuals walk with an abnormal gait, and they do not experience a normal knee joint. This may be one of the causes that up to 20% of total knee arthroplasty individuals are disappointed, and over 50% may have remaining symptoms.

Consequently, the conventional mechanical alignment technique has been recently challenged by a new alternative technique, namely unrestricted kinematic alignment proposed by Howell, as a possible solution to the high dissatisfaction following total knee arthroplasty, aiming at reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.

The restricted kinematic alignment protocol suggested by Vendittoli has been developed as an alternative to the unrestricted kinematic alignment for patients with an outlier or atypical knee anatomy. The restricted kinematic alignment is founded on five principles: hip-knee-ankle angle should be maintained within ± 3° postoperatively; a limitation to a maximum of 5° for lateral distal femoral angle and medial proximal tibial angle may be considered; restoration of collateral ligament balance should be achieved without the gap balancing technique; native femoral anatomy preservation is suggested over tibial one to maintain knee biomechanics; resurface resection must be accomplished on the unworn side with a thickness equivalent to the width of the implant;cut fine-tuning may be sought at the worn side.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients suffered from end stage knee osteoarthritis of grade four according to Kellgren-Lawrence classification in at least one of the three knee compartments, who have an osteoarthritic knees of varus Coronal Plane Alignment of the Knee classification

Exclusion criteria

1. Any valgus malalignment of the knee joint.
2. Malalignment more than 10° or less than 3° varus of knee joint.
3. Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)
4. any tumors or secondary neoplasia diseases
5. Knee joint infection
6. severe cardiopulmonary dysfunction.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Unrestricted kinematic alignment

Experimental group

Description:

reproducing the constitutional tibiofemoral tridimensional alignment and knee laxity. It is almost a pure bone procedure with only exceptional collateral ligament release, which has been shown to reliably position knee components.

Treatment:

Procedure: Total knee arthroplasty

Restricted kinematic alignment

Experimental group

Description:

reproducing patient's constitutional knee anatomy within a safe range while avoiding extreme or pathological anatomies that have been demonstrated to exist.

Treatment:

Procedure: Total knee arthroplasty