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

December 16, 2024 updated by: Sohibe Abdulazeem Ghietah Hussein, Assiut University

Comparison of Restricted Kinematic Alignment Versus Unrestricted Kinematic Alignment in Primary Total Knee Arthroplasty:- Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unrestricted kinematic alignment
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.
Procedure: Total knee arthroplasty
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
Other Names:
  • Total knee replacement
Experimental: Restricted kinematic alignment
reproducing patient's constitutional knee anatomy within a safe range while avoiding extreme or pathological anatomies that have been demonstrated to exist.
Procedure: Total knee arthroplasty
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
Other Names:
  • Total knee replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxoford knee score
Time Frame: 12 months

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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 24 months

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.
24 months
Forgotten Joint Score
Time Frame: 24 months

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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Sohibe A Ghietah, Specialist, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 16, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-2024-100320

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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