Kinematic Versus Mechanical Alignment in Total Knee Replacement

NCT04384913 | Active Not Recruiting

• 1 other identifier: A2-2017-KAvsMA
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.

Conditions

Total Knee Replacement

Keywords

TKA (Total knee arthroplasty); KA (kinematic alignment)

Outcome Measures

Primary Outcomes (3)

• Knee Society Score (KSS)

  The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)

  3 months postoperative

• Knee Society Score (KSS)

  The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)

  12 months postoperative

• Knee Society Score (KSS)

  The Knee Society Scoring System is a validated and responsive method for assessing objective and subjective outcomes after total and partial knee arthroplasty. Minimum: 0 (worst), Maximum: 100 (best)

  24 months postoperative

Secondary Outcomes (9)

• Forgotten Joint Score (FJS-12)

  3 months postoperative

• Forgotten Joint Score (FJS-12)

  12 months postoperative

• Forgotten Joint Score (FJS-12)

  24 months postoperative

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3 months postoperative

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  12 months postoperative

Study Arms (2)

MA (mechanical alignment)

Patients in group MA (mechanical alignment) will be operated according to mechanical implantation technique. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation.

KA (kinematic alignment)

Patients in group KA (kinematic alignment) will be operated according to kinematic implantation technique. The kinematic cutting blocks will be designed to resurface the femoral and tibial bones to restore each patient´s pre-arthritic anatomy and Joint line. Based on a available CT dat the prearthritic anatomy is reconstructed by compensating bone defects and restoring the physiological cartilage height of 1,7mm. Femoral Flexion is evaluated by the anterior Cortex of the distal femur, tibia slope is defined to 3° due to ACL (Anterior Cruciate Ligament) loss, but cab be adapted during surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: * Symptomatic osteoarthritis of the knee * Primary TKA * UCLA\>/= 4 * mMPTA: 85°- 90° * Sum of mMPTA and mLDFA between 3°varus and 2°valgus from neutral Exclusion Criteria: * Minor Patient * Pregnant or breast feeding woman * Difference in the radius of medial and lateral condyles \>2mm * Previous osteotomy around the knee * BMI \>40 * Ligament instability likely to require higher level of constraint * Previous infection or inflammatory disease * Any Patient who cannot or will not provide informed consent for participation in the study

You may qualify if:

• Symptomatic osteoarthritis of the knee
• Primary TKA
• UCLA Score (University of California, Los Angeles Score)\>/= 4
• mMPTA: 85°- 90°
• Sum of mMPTA(mechanical medial proximal tibial angle) and mLDFA(mechanical lateral distal femoral angle) between 3°varus and 2°valgus from neutral

You may not qualify if:

• Minor Patient
• Pregnant or breast feeding woman
• Difference in the radius of medial and lateral condyles \>2mm
• Previous osteotomy around the knee
• BMI \>40
• Ligament instability likely to require higher level of constraint
• Previous infection or inflammatory disease
• Any Patient who cannot or will not provide informed consent for participation in the study

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (1)

Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

Hanover, Lower Saxony, 30625, Germany

Location

Study Officials

• Max Ettinger, Prof. Dr.

  Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 12, 2020
• Study Start: August 1, 2017
• Primary Completion: September 23, 2022
• Study Completion: January 30, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)