Knee-Fix study (Cemented vs Uncemented Total Knee Replacement)

Not Applicable

Active, not recruiting

• Conditions: knee osteoarthritis; Surgery - Surgical techniques; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12616001624471
• Lead Sponsor: orth Shore Hospital Waitemata DHB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-24
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

*The patient is a male or non-pregnant female between the ages of 40-75 years.
*Patient is deemed appropriate for a cruciate retaining knee replacement.
*The patient has a primary diagnosis of osteoarthritis (OA).
*The patient has intact collateral ligaments.
*The patient has signed the study specific, ethics-approved, Informed Consent document.
*The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.

Exclusion Criteria

* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
* Patient has had a previous osteotomy around the knee.
* The patient is morbidly obese (BMI greater than 41).
* The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
* The patient has a varus/valgus malalignment greater than 20 degrees (relative to mechanical axis).
* The patient has a fixed flexion deformity greater than 20 degrees.
* The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
* The patient has a systemic or metabolic disorder leading to progressive bone deterioration or poor bone quality.
* The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
* Patient has a cognitive impairment, an intellectual disability or a mental illness.
* Patients NOT undergoing patellar resurfacing
* The patient is pregnant.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
radiographic assessment of the bone/prostheses interface radiolucencies on plain X-Rays[24 months, 5 years and 10 years after surgery]

Secondary Outcome Measures

Name	Time	Method
Oxford Knee Score[12 months, 24 months, 5 years and 10 years after surgery];Forgotten Knee Score[12 months, 24 months, 5 years and 10 years after surgery];EQ-5D-3L[12 months, 24 months, 5 years and 10 years after surgery];VAS pain[12 months, 24 months, 5 years and 10 years after surgery];International Knee Society score[24 months, 2 years and 5 years after surgery]