Comparison of Restricted Versus Unrestricted Kinematic Alignment in 1ry TKA

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Any valgus malalignment of the knee joint.

Malalignment more than 10° or less than 3° varus of knee joint.

Ligamentous laxity of the affected knee (medial or lateral collateral ligaments)

any tumors or secondary neoplasia diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total knee arthroplasty

    Procedure/Surgery

    Total knee arthroplasty (TKA) is a common orthopaedic surgery that involves replacing the articular surfaces (femoral condyles and tibial plateau) of the knee joint with smooth metal and highly cross-linked polyethylene plastic

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Unrestricted kinematic alignmentExperimental treatment 0 interventions
Group B: Restricted kinematic alignmentExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

Oxoford knee score

The Oxford Knee Score is a 12-item patient-reported outcomes specifically designed and developed to assess function and pain after total knee replacement arthroplasty. It is short, reproducible, valid and sensitive to clinically important changes. Score each question from 0 to 4 with 4 being the best outcome. This method, when summed, produces overall scores running from 0 to 48 with 48 being the best outcome

Time frame
12 months

Secondary outcomes

1

Knee Injury and Osteoarthritis Outcome Score

The Knee Injury and Osteoarthritis Outcome Score is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The questionnaire is self-administered and assesses five outcomes: pain(9 items), symptoms(7 items), activities of daily living(17 items), sport and recreation function(5 items), and knee-related quality of life (4 items). The questionnaire meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome. A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

Time frame
24 months
2

Forgotten Joint Score

The Forgotten Joint Score was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee. This questionnaire shows its strengths in patients with a good level of knee function and a low pain level. It has been designed specifically to reduce ceiling effects commonly associated with many patients reported outcome measures in this patient group, e.g. when assessing short- to mid-term results in total knee arthroplasty patients. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100) For the final 'Forgotten Joint Score -12' a high score indicates good outcome.

Time frame
24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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