Skip to content

An Investigation into the Clinical Performance of the Medacta Masterloc Stem in patients undergoing Total Hip Replacement Procedures

An Investigation into the Clinical Performance of the Medacta Masterloc Stem in patients undergoing Total Hip Replacement Procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000586617
Enrollment
105
Registered
2023-05-30
Start date
2021-03-15
Completion date
2022-08-18
Last updated
2023-06-05

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

Conditions

None listed

Brief summary

In a total hip replacement (THR), also called total hip arthroplasty, the damaged bone and cartilage is removed and replaced with prosthetic components. Secondary stability of the femoral stem is a prerequisite to secondary bone ingrowth and proper long-term fixation. Initial or primary stability of uncemented stems depends either on filling the proximal femur with intimate contact between the stem and the anatomic shape of the proximal femur (an anatomic fit) or filling the femoral diaphysis. The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. The stem features a shortened stem length and reduced distal geometry. It is coated, using a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to to assist with biological fixation. The aim of this study is to assess patient satisfaction and clinical outcomes following placement of a MasterLoc Stem for Total Hip Arthroplasty.

Interventions

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. During THA, the damaged bone and cartilage is removed and replaced with several prosthetic components, including a femoral stem and acetabular cup. The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. This uniquely designed stem offers three offset op

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. During THA, the damaged bone and cartilage is removed and replaced with several prosthetic components, including a femoral stem and acetabular cup. The MasterLoc HA femoral stem is a cementless flat dual tapered wedge stem, designed to restore the anatomy of the patient enhancing mediolateral stability with reduced removal of bone. This uniquely designed stem offers three offset options within an 11 mm range that do not change leg length. Furthermore, it is coated with a proprietary technology, called Mectagrip, with plasma sprayed titanium and hydroxyapatite to assist with biological fixation. The newly designed MasterLoc Stem device has been introduced into the Australian market, however, its short and long-term performance is yet to be evaluated. The purpose of this current investigation will be to observe the level of patient satisfaction reported following implantation of a MasterLoc stem. Patients who are planned to undergo THA surgery and fit the eligibility criteria will be considered for enrolment in this study. The stem will be implanted by qualified and experienced orthopaedic surgeons as per routine practice. The duration of the procedure will take approximately 1-1.5 hours, as per a standard THA. Adherence to the intervention will be monitored through radiological examination for stem loosening using the routine radiographs taken at post-operative visitation as part of the surgeon's standard of care.

Sponsors

Medacta Australia Pty Ltd
Lead SponsorCommercial sector/Industry

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 75 Years
Healthy volunteers
No

Inclusion criteria

Patients with symptomatic arthritis who are candidates for a primary total hip replacement with an uncemented femoral stem as determined jointly by the surgeon and the patient. Patients able to give informed consent Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up

Exclusion criteria

Patients who have had a previous total hip replacement or hip fusion of the affected hip Pregnant women or those seeking to become pregnant Patients with a history of active infection Patients who are a prisoner, currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, or known alcohol or substance abuse Patients who are immunologically suppressed

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026