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Evaluation of anatomical head center, gait and bone re-modelling after Total hip replacement – Randomized controlled trial of neck preserving versus conventional hip prosthesis

A Single Centre, Participant-Blinded, Randomized, 12 Month, Parallel Group, Trial Of The Anatomical Head Center, Gait And Bone Remodelling After Total Hip Replacement Using Cementless Neck Preserving Versus Conventional Hip Prosthesis

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000796583
Enrollment
40
Registered
2015-07-31
Start date
2015-08-10
Completion date
2015-10-14
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

This clinical study is a single centre, prospective, randomized, participant-blinded trial enrolling 40 patients to receive either a Cementless Neck Preserving stem or a Conventional Hip stem Prosthesis. Neck preserving prostheses to offer a more physiological load transmission across the femur, the nature of achieving a stable press-fit means that the stem must adapt to the geometry of the bone. As patient anatomy is highly variable, there is limited ability to adjust the femoral offset, centre of rotation, femoral anteversion and leg length. It is unclear whether anatomical restoration, offered by neck preserving prostheses is comparable to conventional prostheses. The success of the neck preserving systems relies on the precise positioning and sizing of the implant and the excellent long-term durability of the ceramic bearings. Hence, we propose a randomized comparative study to assess and compare the anatomical head centre, gait analysis and bone remodelling of two parallel groups receiving either a Neck preserving or a Conventional hip stem prosthesis by the direct anterior approach. Antero-posterior and modified Budin x-rays will be analysed at preoperatively, 3 months, 12 months, 2 years and 5 years to assess femoral head offset, stem orientation and leg length. DEXA (bone density) scans will be assessed pre-operatively and 12 months to measure femoral bone density, with the aim of assessing bone remodelling after total hip replacement. Spatial-Temporal gait analysis will be used to quantify measurement of standard gait (6 minute walking test – 6MWT) and sit-to-stand preoperatively, 3 months and 12 months. Standard, functional parameters will be assessed pre-operatively, 3 months, 12 months, 2 years and 5 years.

Interventions

The intervention involves the surgical replacement of the hip joint performed by an orthopaedic surgeon using the Minihip Stem (Corin Ltd) hip prosthesis. This stem is designed as a femoral neck preserving, short prosthesis with the philosophy of bone preservation in the proximal area (metaphysis) of the femur. Surgical approach will be via the direct anterior approach. Approximate duration of the surgical procedure is 60-90 minutes.

Sponsors

CORIN (Australia) Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

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

Eligibility

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

Inclusion criteria

1. Eligible for a primary total hip replacement 2. Dorr type A femur 3. Willing to comply with the protocol 4. Willing and competent to consent

Exclusion criteria

1. Not meeting the inclusion criteria 2. Any patient with a revision / resurfacing or a hemi hip replacement 3. Patients with a Dorr type B or C femur 4. Cemented hip replacement 5. Medically Unfit for surgery 6. Not willing to comply with the protocol 7. Not willing or competent to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026