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Trial registered on ANZCTR


Registration number
ACTRN12617000388314
Ethics application status
Approved
Date submitted
24/02/2017
Date registered
16/03/2017
Date last updated
1/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the Range of Motion of 200 Patients at Least Five Years after the Delta Motion Ceramic-on-Ceramic Hip Replacement Procedure
Scientific title
A Minimum Five-Year Follow-Up of the Stability of 200 Patients With Delta-Motion Ceramic-on-Ceramic Hip Replacements
Secondary ID [1] 291260 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic arthritis of hip 302193 0
Condition category
Condition code
Musculoskeletal 301802 301802 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 297351 0
Diagnosis / Prognosis
Intervention code [2] 297481 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301207 0
Range of motion of the Delta Motion Ceramic on Ceramic Hip assessed by a clinical examination by the investigator surgeon with the aid of a goniometer.
Timepoint [1] 301207 0
5 years post hip replacement surgery
Primary outcome [2] 301234 0
Head engagement of the Delta Motion Ceramic on Ceramic Hip assessed by physical examination by the investigator surgeon.
Timepoint [2] 301234 0
5 years post hip replacement surgery
Primary outcome [3] 301235 0
Stability of the Delta Motion Ceramic on Ceramic Hip assessed by post surgery complications to measure component dislocations and squeaking. Component orientation will be observed using x-ray analysis.
Timepoint [3] 301235 0
5 years post hip replacement surgery
Secondary outcome [1] 332028 0
Complications such as ceramic breakage, dislocation, impingement and squeaking will be assessed by clinical review and X-ray analysis.
Timepoint [1] 332028 0
2 and 5 years post hip replacement surgery.
Secondary outcome [2] 332070 0
Component positioning will be assessed using X-ray analysis
Timepoint [2] 332070 0
5 years post hip replacement surgery.
Secondary outcome [3] 332071 0
Bone in-growth will be assessed using X-ray analysis
Timepoint [3] 332071 0
5 years post hip replacement surgery.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
200 patients have been recruited for follow-up as defined in this protocol. The study is adequately powered to show a statistically significant improvement in clinical outcomes compared with published literature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7550 0
Mater Sydney - North Sydney
Recruitment postcode(s) [1] 15452 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 295732 0
Commercial sector/Industry
Name [1] 295732 0
DePuy International Ltd
Address [1] 295732 0
St. Anthony’s Road
Leeds
LS11 8DT
Country [1] 295732 0
United Kingdom
Primary sponsor type
Individual
Name
Associate Professor W L Walter
Address
Specialist Orthopaedic Group
3 - 9 Gillies Street
Suite 1.08, Level 1
Mater Clinic Building
Wollstonecraft
NSW 2065
Country
Australia
Secondary sponsor category [1] 294579 0
None
Name [1] 294579 0
Address [1] 294579 0
Country [1] 294579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297036 0
St Vincent's Hospital Sydney
Ethics committee address [1] 297036 0
97-105 Boundary Street
Darlinghurst
NSW 2010
Ethics committee country [1] 297036 0
Australia
Date submitted for ethics approval [1] 297036 0
26/09/2011
Approval date [1] 297036 0
10/10/2011
Ethics approval number [1] 297036 0
11/163

Summary
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.
Trial website
Trial related presentations / publications
None
Public notes
All patients in the investigators practice sign an ethics approved consent form to collect data specific to their procedure. The patients included in this study all signed the consent form and data was collected; ethics was applied for to allow publication of the data, hence ethics for this specific review was obtained after the first patients were consented.

Contacts
Principal investigator
Name 55294 0
A/Prof William L Walter
Address 55294 0
Specialist Orthopaedic Group
Suite 1.08 (Level One)
3 – 9 Gillies Street
Wollstonecraft
NSW 2065
Country 55294 0
Australia
Phone 55294 0
+61 (0)2 8920 3388
Fax 55294 0
Email 55294 0
bill.walter@hipknee.com.au
Contact person for public queries
Name 55295 0
Dr Jenny Burke
Address 55295 0
Specialist Orthopaedic Group
Suite 1.08 (Level One)
3 – 9 Gillies Street
Wollstonecraft
NSW 2065
Country 55295 0
Australia
Phone 55295 0
+61 (0)488 240471
Fax 55295 0
Email 55295 0
jennyburke@neosurgical.com.au
Contact person for scientific queries
Name 55296 0
A/Prof William L Walter
Address 55296 0
Specialist Orthopaedic Group
Suite 1.08 (Level One)
3 – 9 Gillies Street
Wollstonecraft
NSW 2065
Country 55296 0
Australia
Phone 55296 0
+61 (0)2 8920 3388
Fax 55296 0
Email 55296 0
bill.walter@hipknee.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary