CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 167 enrolled
Drug / intervention
BoneMaster coated acetabular shell. +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00859976
NCT00859976N/ACompleted

Prospective Randomised Control Trial to Compare the Effect Upon Bone Density and Clinical Outcomes When Using BoneMaster HA Coated Acetabular Cups Compared With Plasma Sprayed HA Coated Cups in Patients With Total Hip Replacements

Zimmer Biomet·interventional·Posted Mar 11, 2009·Updated Mar 5, 2019

In Brief

A clinical study evaluating BoneMaster coated acetabular shell. and Plasma Coated Acetabular Shell for Arthropathy of Hip. Completed, enrolled 167 participants across 1 site.

Detailed Summary

The randomised controlled trial will be carried out on patients that require a total hip replacement (THR) to reduce pain and restore their function. One way of fixing the hip joint to the bone is by coating the implant to encourage the body to grow bone onto the replacement hip. This study is aiming to find out whether the new (Bonemaster) coating allows increased bony growth onto the cup when compared to the usual (plasma-sprayed) coating. This may reduce the incidence of early failures due to poor bony attachment, which is a well known complication for early failure of total hip replacements. The study will compare two different types of coating (BoneMaster and Plasma-sprayed) on the cup of the replacement hip. Density of the bone immediately surrounding the cup will be observed to see if there are differences between the two groups. The density of bone will be measured using standard x-ray assessment and in a smaller sample of 14 patients, using a special scan called Dual Energy X-ray Absorptiometry (DEXA Scan). Functional comparisons will be assessed through clinical scores.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2012
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.3 years ago

Interventions

BoneMaster coated acetabular shell.device

Bonemaster coated Exceed Acetabular Shell

Plasma Coated Acetabular Shelldevice

Plasma HA coated Exceed Acetabular Shell