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Alignment in Total Knee Replacement: A Randomised Controlled Study Comparing Intramedullary Alignment Systems with Patient Specific Instrumentation

Alignment in Total Knee Replacement: A Randomised Controlled Study Comparing Intramedullary Alignment Systems with Patient Specific Instrumentation

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000698976
Enrollment
200
Registered
2011-07-07
Start date
2011-08-01
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

Alignment of total knee replacement is of importance with regards to the length of survivorship. Currently a rod is passed down the centre of both the tibia and the femur so as that the correct bone cuts are made in order the prosthesis fits the bone in the correct alignment. New technology now exists that enables custom cutting blocks to be manufactured specifically for that individuals patients knee so as the bone cuts made are as accurate as possible. This involves undergoing an MRI scan of the knee and from this the cutting blocks specific for the patients knee are made. This new technology is used to aid in establishing the correct bone cuts in the tibia and femur and hence ultimately the overall alignment of the knee replacement. The knee replacement used will be the same type in each group and the method of insertion will be the same. Post-operatively both groups will undergo a CT scan of the knee in order to establish the precise alignment of the knee replacement in relation to bony landmarks. From this we can establish whether or not there is any difference between the two different methods of bone preparation in the overall alignment of the knee replacement.

Interventions

Patient Matched Instrumentation - ie custom made cutting blocks in preparation for total knee replacement. Patients undergoing a TKR using the Visionaire technology will have an MRI scan of their knee from which specific cutting blocks will be manufactured to match precisely the architecture of their knee. These cutitng blocks are made from nylon material and are single use for that patient and disposed off after the procedure. The aim of this study is to determine whether the surgical time is

Patient Matched Instrumentation - ie custom made cutting blocks in preparation for total knee replacement. Patients undergoing a TKR using the Visionaire technology will have an MRI scan of their knee from which specific cutting blocks will be manufactured to match precisely the architecture of their knee. These cutitng blocks are made from nylon material and are single use for that patient and disposed off after the procedure. The aim of this study is to determine whether the surgical time is reduced along with confirming the accuracy of the technique in terms of overall alignment of the prosthesis. we would expect surgical time to be similar if anything slightly shorter.

Sponsors

Smith and Nephew
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Osteoarthritis of the Knee

Exclusion criteria

Unable to have MRI

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026