A study looking at whether or not a knee replacement moves inside the bone that it is inserted into and if it does move, this movement will be measured using x-rays.

Not Applicable

Withdrawn

• Conditions: on-inflammatory osteoarthritis of the knee; Non-inflammatory osteoarthritis of the knee; Musculoskeletal - Osteoarthritis; Surgery - Surgical techniques

• Registration Number: ACTRN12610000855022
• Lead Sponsor: De Puy International

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Consent
2. Non-inflammatory osteoarthritis of the medial
compartment of the knee
3. A mechanical axis deformity less than 10degrees varus
or 5 degrees valgus
4. An intact anterior cruciate ligament without medial-lateral
subluxation
5. A flexion contracture less than 10degrees
6. Body weight less than 90kg

Exclusion Criteria

1. Patients with active infection
2. Patients requiring total knee replacement surgery
3. Patients requiring revision surgery of a previously implanted unicompartmental knee
4. Patients with presence of malignancy in the area of the involved knee joint
5. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule
6. Patients with a physical condition (ie. weight exceeding 90kgs) or a neuromuscular deficit which interferes with the patient's ability to limit weight-bearing or places an extreme load on the implant during the healing period
7. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Examine the amount of three-dimensional (3D) micromotion of a metal backed unicompartmental tibial component using a computer aided design (CAD) model based RSA (Group1) and then compare the results with unicompartmental tibial component RSA studies published in the literature (Group 2)[Each patient will be evaluated pre-operatively and then at 1 week, 4 months, 1 year and 2 years post-operatively]

Secondary Outcome Measures

Name	Time	Method
il[Nil]