Patient Outcomes Following Kinematic and Functional Alignment in Robotic-Assisted Total Knee Arthroplasty With Randomized Insert Types

MI-összefoglaló

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The trial is looking for adults with knee osteoarthritis who are having a robot-assisted total knee replacement with the VELYS system. People are randomly given one of two insert types.

Életkor

18 years and older

Nem

All sexes

A betegség stádiuma

Knee osteoarthritis (wear-and-tear arthritis of the knee) that needs surgery

Korábbi kezelés

People having a repeat (revision) knee replacement cannot join.

A részvétel fő kizáró okai

• Repeat (revision) knee replacement surgery
• An active infection
• Not able to come to follow-up visits
• Severe other illnesses that may affect the surgery or taking part

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

This study aims to evaluate patient outcomes following robotic-assisted total knee arthroplasty using the VELYS system. Patients undergoing surgery will receive either kinematic alignment or functional alignment as determined by the operating surgeon as part of routine clinical care. Within each surgical technique group, patients will be randomly assigned to receive different implant insert types (medial stabilised or cruciate retaining) using a REDCap-based randomisation process. Patient-reported outcome measures will be collected before surgery and at follow-up time points after surgery to assess clinical outcomes.

A vizsgálat 4 csoportja

• Kinematic Alignment + Medial Stabilized InsertA vizsgált kezelés

  Patients undergoing kinematic alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

  Kezelés: Medial Stabilized Insert

• Kinematic Alignment + Cruciate Retaining InsertA vizsgált kezelés

  Patients undergoing kinematic alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

  Kezelés: Cruciate Retaining Insert

• Functional Alignment + Medial Stabilized InsertA vizsgált kezelés

  Patients undergoing functional alignment with medial stabilised insert in robotic-assisted total knee arthroplasty.

  Kezelés: Medial Stabilized Insert

• Functional Alignment + Cruciate Retaining InsertA vizsgált kezelés

  Patients undergoing functional alignment with cruciate retaining insert in robotic-assisted total knee arthroplasty

  Kezelés: Cruciate Retaining Insert