Primary stability of cemented vs uncemented stems in revision total knee arthroplasty measured with RSA: a randomised controlled trial.

Phase 3

Completed

• Conditions: failure primary total knee prosthesis; osteoartritis; 10023213; 10005944

• Registration Number: NL-OMON39918
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2016-07-14
• Study Completion: 2020-06-26
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

- patient requires a revision of his primary total knee replacement and the Legion system with both experimental implantation techniques is indicated in this patient.
- patients is willing to consent to participate in the study by signing and dating an IRB-approved consent form.
- patient plans to be available for follow-up through five years postoperative.
- patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
- patient has radiologically defined Type I or Type IIa/b bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.

Exclusion Criteria

- patient has radiologically or per-operatively defined Type III bone loss according to Anderson Orthopedic Research Institute Bonestock Classification.
- patient has a BMI>35.
- patient has an active, local infection or systemic infection.
- patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
- patient has an immunosuppressive disorder (chronic condition characterized by markedly inhibited ability to respond to antigenic stimuli).
- patient has a known sensitivity to materials in the device.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary researchparameter is stability of the prosthesis measured with RSA,<br /><br>expressed in migration of the prosthesis components.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Peri-operative data (operative time, blood loss), Knee Society Score, active<br /><br>flexion, passive range of motion, VAS pain and VAS satisfaction.</p><br>