Assessing the Range of Motion of 200 Patients at Least Five Years after the Delta Motion Ceramic-on-Ceramic Hip Replacement Procedure

A Minimum Five-Year Follow-Up of the Stability of 200 Patients With Delta-Motion Ceramic-on-Ceramic Hip Replacements

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12617000388314

Enrollment

206

Registered

2017-03-16

Start date

2011-07-27

Completion date

2015-06-10

Last updated

2017-12-16

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

Conditions

None listed

Brief summary

Two hundred primary hip replacements with Delta-Motion heads and cups were performed between December 2008 and December 2009 and were followed-up for a minimum of five years. The two hundred patients have been reviewed at regular intervals, and data has been obtained from the patients pre-operatively, and post-operatively at 6 weeks, 6 months or 1 year, and at a minimum of 5 years. Patient outcome were assessed using The Harris Hip Score and X-rays were taken for radiographic evaluation. The aim of the study is to measure clinical and radiographic outcomes such as ceramic breakage and squeaking to verify the clinical effectiveness of the product that is new to the market. The primary objective of the study is to investigate the clinical outcome of the Delta-Motion hip system and to demonstrate improved range of motion, head engagement and stability of the replaced hip. The null hypothesis is that the large diameter ceramic on ceramic bearing will not improve patient outcomes compared with published data. Complications will also be assessed and x-rays will be used to validate component positioning and quality of bone in-growth.

Interventions

Two hundred patients with Delta Motion Ceramic on Ceramic hip replacements that were performed between December 2008 and December 2009 were followed-up for a minimum of five years. The study will measure the clinical and radiographic outcomes such as hip stability, ceramic component breakage and squeaking with motion, to verify the clinical effectiveness of the product at 5 years post-operatively.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients must have undergone primary hips surgery due to osteoarthritis 2. Patients must have had a Delta-Motion head and cup implanted 3. Surgery must have been performed by Associate Professor William L Walter or William K Walter 4. Patients must be over 18 years of age 5. Patients must understand the conditions of the study and must be willing to participate for the length of the prescribed term of follow-up and rehabilitation 6. Patients must be capable of, and have given informed consent to their participation in the study

Exclusion criteria

1. Patients who underwent concomitant procedures as part of their surgery 2. Patients who have clinically diagnosed complications with other major joints 3. Patients with an inability to complete post-surgery physical therapy or return for follow-up visits

Outcome results