Clinical trial NCT06726993: Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA
Official title: Comparison of Restricted Kinematic Alignment Versus Unrestricted Kinematic Alignment in Primary Total Knee Arthroplasty:- Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis (OA) of the Knee
Total Knee Anthroplasty
Keywords: Total knee arthroplasty
TKA
Total knee replacement
TKR
Restricted kinematic alignment
rKA
Kinematic alignment
KA
Unrestricted kinematic alignment
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oxoford knee score
timeFrame: 12 months
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: 24 months
measure: Forgotten Joint Score
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Sohibe A Ghietah, Specialist
role: PRINCIPAL_INVESTIGATOR
References:
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