Bone remodelling and density of the pelvis following implantation of the delta TT acetabular cup in patients undergoing primary total hip replacement for hip arthritis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000003178

Enrollment

Registered

2019-01-08

Start date

2014-01-13

Completion date

2015-11-09

Last updated

2021-12-27

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 hip engineering and surgery are in a state of constant research development and improvement. The literature presents a plethora of alternative bearing materials and combinations as well as geometries, dimensions and fixation methods. Despite continued popularity of hip arthroplasty as effective treatment for patients experiencing end stage osteoarthritis, the acetabular component of the arthroplasty remains a limiting factor in the longevity of the arthroplasty. Cup wear and aseptic loosening are the main causes of failure. These have been associated with micro-motion in modular components and non fixation of the bone-implant interface. The Delta-TT cup uses a combination of the modularity of the Delta acetabular system with the porous structure of the Trabecular Tritanium. The Delta-TT cup is made of Ti6AI4V tritanium alloy which is bio-compatible and effective in biological fixation and has been used in the orthopedic sector for over 30 years. Bone density is a good indicator of the bone's response to implantation and its potential longer term success. Bone remodeling behavior following arthoplasty may be investigated radiographically. DEXA measurements are the gold-standard for measuring bone mineral density (BMD) and have been used extensively in clinical practice. Although DEXA is an established assessment technique in proximal femurs, there are relatively few reports in BMD in the acetabular region following total hip arthroplasty. In cases where clinical data is not yet available, it is desirable to predict the mid-term outcomes of an arthroplasty. Bone remodeling algorithms may be used with computer modelling techniques to detect these bony remodeling changes. Using this methodology it is possible to analyse more than one design in a parametric and comparable manner, at a minimal cost to the patient, designer and manufacturer. To our knowledge, however only one study has predicated bone remodeling behavior in the acetabulum following total hip arthroplasty. This method has been validated using data in the literature. It is proposed in this study to carry out a clinical DEXA study and a bone remodeling analysis of the Delta-TT cup.

Interventions

Patients undergoing primary total hip replacement for osteoarthritis of the hip. Intervention was by one of two experienced consultant orthopaedics surgeons (hip specialists). DEXA scans were used to measure the bone mineral density behind the cup at various intervals post op.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients with rheumatoid or osteoarthritis of the hip who are candidates for a primary total hip replacement.

Exclusion criteria

Patients with active infection, acute hip fracture, Patients who have had previous hip surgery. Patients with presence of malignancy in the hip joint area. Patient having surgery with other types of components. Patients who are mentally incompetent or unlikely to be compliant with the prescribed follow up evaluation schedule. Patients greater 125kg. Patients with a neuromuscular or concurrent illness which may affect their outcome.

Outcome results