Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not

NCT06264999 | Withdrawn FDA Device

• 1 other identifier: 427976
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty. The main questions it aims to answer are: Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform

• Gait analysis
• Stair performance test
• CT based Micromotion analysis of the implant micromovement

Conditions

Arthritis Knee; Arthroplasty; Gait Analysis

Outcome Measures

Primary Outcomes (2)

• Preferred walking speed (meter/minute) after surgery

  Evaluation of gait with preferred walking speed (meter/minute) measured on a electronic walkway system

  twelve months after surgery.

• CT-RSA measured maximum total point of motion(MTPM)

  CT-RSA measured maximum total point og motion(MTPM)in millimeters and rotation of the implant in degrees compared to baseline value

  6,12 and 24 months after surgery

Secondary Outcomes (14)

• evaluation of max walking speed(m/minute)

  twelve months after surgery.

• stride length(cm)

  twelve months after surgery.

• step length in mid stance phase (cm)

  twelve months after surgery.

• single leg support time(s)

  twelve months after surgery.

• double-leg support time(s)

  twelve months after surgery.

Other Outcomes (2)

• A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º

  8 weeks

• Presence of eminence fractures

  2 days postoperatively

Study Arms (2)

Journey II CR

ACTIVE COMPARATOR

Implantation of Journey II CR sacrificing the anterior cruciate ligament.

Device: Journey II CR

Journey II XR

ACTIVE COMPARATOR

Implantation of Journey II XR retaining the anterior cruciate ligament.

Device: Journey II XR

Interventions

Journey II CR DEVICE

Implantation of Journey II CR Crucite Retaining Knee

Journey II CR

Journey II XR DEVICE

Implantation of Journey II XR Bi Cruciate Retaining Knee

Journey II XR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe osteoarthritis Ahlbäck grade 3 or 4 affecting 2-3 compartments
• Ability to preoperatively walk 30 m independently without support before surgery
• Ability to give written consent.
• CPAK (Coronal Plane alignment of the Knee) I, II or III

You may not qualify if:

• Previous cruciate ligament surgery in affected knee
• Previous osteotomy in affected knee,
• Posttraumatic arthritis in affected knee
• History of infectious arthritis
• Rheumatoid arthritis
• Significant preoperative varus or valgus deformity \>15º
• Evidence of damaged Anterior Cruciate Ligament and/or Posterior Cruciate Ligament
• Flexion contracture \> 10 º, - Planning reveals the need for a complex implant ( stem, augment or higher level of constraint).

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

St.Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

Location

Study Officials

• Tina Strømdal-Wik, MD, PhD

  <St Olav- NTNU?

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: February 20, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

NO (1)