Skip to content

A prospective, observational, cohort study of the MASTER-SL Femoral stem in patients with degenerative disease of the hip

In patients with Osteoarthritis of the hip undergoing a Total Hip Replacement, how does the MASTER-SL femoral stem perform under standard conditions with regards to clinical outcomes.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000550303
Enrollment
50
Registered
2017-04-19
Start date
2014-10-28
Completion date
2015-10-30
Last updated
2021-10-11

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

Conditions

None listed

Brief summary

Factors for operative treatment include severity of diseases that affect the hip, symptoms, clinical finding on physical examination and radiological assessment of the hip. When referring to total hip replacement (THR) surgery, both the acetabular socket and the head of the femur are replaced with a suitable prosthetic device consisting of a cup fitted into the acetabulum (socket) and a new head (ball) with stem fitted into the upper shaft of the femur. Two major factors influence the outcome of THR (outside the surgery process itself) and these are the fixation of the components to the bone and wear of the implanted surfaces. (between the ball and socket). THR is an extremely successful operation due to continuous improvements in surgical techniques, bio-materials and implant design. It is necessary however, to safely evaluate new advances in the design of hip replacement components so that improvements are sought to continually enhance patient outcomes. The design and materials used in the MASTER-SL femoral implant are very similar to other prosthesis already used by surgeons. The aim of this trial is to assess the clinical performance of the MASTER-SL femoral stem over a two year period under standard condition of use in THR.

Interventions

50 patients to undergo Total Hip Replacement, the prosthesis used for the trial is MASTER-SL femoral stem. Patients will be followed up for functional and radiological assessments and side effects for a minimum of two years post surgery.

Sponsors

The Orthopaedic Institute of Queensland (ORIQL)
Lead SponsorOther

Eligibility

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

Inclusion criteria

Male and female >18 years; radiologically confirmed diagnosis of primary osteoarthritis (OS) of the hip and suitable for primary total hip replacement; Life expectancy of > 10 years Receiving a MASTER-SL femoral stem Voluntary written informed consent obtained

Exclusion criteria

Prospect for recovery to independent mobility compromised by known coexistent, medical problems; Requiring revision hip replacement; Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip join; Previous organ transplant; Previous hip replacement (resurfacing or THR) on the contra-lateral side within the last 6 months; Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points; Body mass index > 40 kg/m2 Active or suspected infection; Known sensitivity to device materials; Pregnant woman

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026