Skip to content

Clinical Outcomes of Increased Flexion Total Knee Replacement.

A randomised controlled trial to evaluate knee range of motion (ROM), pain and functional outcomes of patients after primary total knee arthroplasty (TKA) for knee osteoarthritis with the Increased Flexion Profix Total Knee System (Smith & Nephew, Inc.).

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000325505
Enrollment
40
Registered
2006-07-31
Start date
2006-06-13
Completion date
2008-12-31
Last updated
2024-07-08

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

Conditions

None listed

Brief summary

Total knee arthroplasty (TKA) is a common, successful and safe operation for people who have end-stage knee arthritis. Pain-free knee flexion or bend of 135 degrees or more with stability is the goal of TKA. There are substantial improvements in pain and function. However, a major problem that persists is that patients do not consistently achieve knee flexion or bend greater than 110 degrees. The need to improve surgical technique and prosthetic designs to provide better flexibility and function is therefore essential. Many designs are available and currently in use. This study involves the use of one of these designs; the Profix Total Knee System (Smith & Nephew, Inc.). This system gives the surgeon the option to implant the prosthesis onto the leg using either increased flexion or standard instruments. The instruments are used by the surgeon to ensure accurate placement of the prosthesis. The objective of this study is to compare knee flexion range of motion (ROM), pain and functional outcomes of patients after primary TKA with the Profix Total Knee System. The primary hypothesis is that patients who have Profix TKA’s implanted by the surgeon with increased flexion instruments will achieve significantly greater knee flexion than those implanted with standard instruments. The secondary hypothesis is that this increased knee flexion will allow improved functional ability with less pain and as a result better quality of life. The trial is a double blind study with patients, assessors and data analysts blinded to group allocation

Interventions

Total knee arthroplasty with the Profix Total Knee System (Smith & Nephew, Inc). This system enables the surgeon to implant the femoral prosthesis in a 4 degree flexed position (increased flexion technique) or in a neutral position (standard technique)

Sponsors

Mater Health Services
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults listed for total knee replacement at the Mater Adult Hospital, with a diagnosis of non-inflammatory degenerative joint disease, who will be available for follow-up evaluations for 2 years.

Exclusion criteria

Active local or systemic infection, patients undergoing revision knee or complex primary arthroplasty, patients who are to have bilateral knee arthroplasty or those who have had knee arthroplasty in the previous 12 months. Pre-existing severe osteoporosis, or any other systemic or metabolic disorders causing progressive deterioration of bone.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 25, 2026