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.

Patients with non-inflammatory osteoarthritis requiring a partial knee replacement will have tantalum beads inserted at the time of surgery in order to reference implant movement over time and these results will be compared with results from the literature of others with partial knee replacements.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000855022

Acronym

Nil

Enrollment

Registered

2010-10-14

Start date

2010-09-27

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate the amount of movement, if any, of a metal backed partial knee replacement using x-rays taken at follow-up visits. A computer program will be used to analyse the x-rays to measure if the replacement has moved and how much it has moved since it was put in or since the previous follow-up visit.

Interventions

Partial knee replacement with the addition of between 5 and 9 Tantalum beads (metal beads 1mm in diameter) will be inserted into each of the proximal tibial and distal femoral bones. These beads define rigid bodies in order to reference the implants to for measurement purposes. The amount of time taken to insert the beads will be approximately 5 minutes longer than standard knee replacement surgery. The number of beads inserted is determined by the need to be able to clearly identify them an

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results