Efficacy evaluation of the AK Medical ACCK? constrained knee prosthesis in total knee arthroplasty: a prospective multicenter clinical and radiological follow-up study

Phase 1

• Conditions: osteoarthritis of the knee

• Registration Number: ChiCTR2400088920
• Lead Sponsor: Honghui Hospital, Xi'an Jiaotong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age =18 years and =85 years.<br>2. have been clinically diagnosed with knee disease, have undergone TKA with poor postoperative outcome, and have failed to improve with conservative treatment or have progressed to the point where total knee revision surgery is required (revision surgery is defined as any surgery in which both tibial and femoral components are replaced. Patients were excluded if they (1) had only a polyethylene liner replaced during aseptic revision surgery, (2) had a debridement procedure without component replacement during infectious revision, (3) had unavailable or inadequate radiographs or clinical scores, and (4) had a follow-up period of < 24 months.<br>3. Meet the indications for revision of the AK Medical ACCK II knee prosthesis (Indications: ? Femoral/tibial side bone defect, both tibial and femoral components are loose and cannot be stably fixed (need to be used with an extension bar for fixation) ?. Lateral tibial collateral ligament instability, the initial replacement prosthesis has been unable to provide stability ? aseptic loosening caused by prosthesis failure, failure of the initial replacement surgery, poor joint stability, ligament dysfunction.)<br>4. Possess good general condition, able to tolerate surgery and postoperative rehabilitation.<br>5. Possess normal cognitive ability and communication skills to understand the purpose of the study and potential risks.

Exclusion Criteria

1. Age <18 years or >85 years.<br>2. History of previous revision knee surgery or presence of other serious joint disease.<br>3. Presence of severe systemic diseases that cannot tolerate surgery (rheumatoid arthritis, infectious arthritis, cardiac disease, liver disease, kidney disease, other diseases that cannot tolerate surgery and postoperative rehabilitation process).<br>4. Presence of mental illness (major depression, anxiety, other mental illnesses that may affect the proper conduct of the study).<br>5. Women who are pregnant or breastfeeding.<br>6. History of allergy to study-related drugs or materials.<br>7. Already participating in other clinical studies.<br>8. Anticipated inability to complete the follow-up visits required by the study (visual or mental or physical limitations that prevent the patient from completing the questionnaires on his/her own, e.g., living far away from the study centre, busy work schedule).<br>9. Legal factors: subjects have legal disputes or restrictions that prevent them from participating properly in the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
KSS;

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities(WOMAC);SF-12;Knee range of motion;Patient satisfaction;Rate of complications;Surgery-related indicators (duration of surgery, length of hospital stay);Imaging Evaluation;