Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000832471p
Ethics application status
Submitted, not yet approved
Date submitted
18/06/2016
Date registered
24/06/2016
Date last updated
24/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the kinematics on participants with either Mobic or M6C artificial cervical discs.
Scientific title
Retrospective evaluation of neck range of motion in patients who have undergone either MOBIC or M6C cervical disc arthroplasty
Secondary ID [1] 289488 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical disc degeneration 299186 0
Condition category
Condition code
Surgery 299192 299192 0 0
Surgical techniques
Musculoskeletal 299228 299228 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with either MOBIC or M6C cervical disc arthroplasty will be identified retrospectively. X-rays will be taken within 3 months of surgery. Their post-operative x-rays will be examines for disc kinematics.
Intervention code [1] 295076 0
Not applicable
Comparator / control treatment
Patients with either MOBIC or M6C disc replacements. These are the two most commonest disc prosthesis used.
Control group
Active

Outcomes
Primary outcome [1] 298672 0
Outcome will be range of movement for neck flexion and extension. This will be assessed by evaluation of post-operative x-rays.
Timepoint [1] 298672 0
3 months post-cervical disc replacement.
Secondary outcome [1] 324938 0
NIL
Timepoint [1] 324938 0
NIL

Eligibility
Key inclusion criteria
Patients at a single institution whom had MOBIC or M6C disc replacement by a single senior surgeon. Patients whom were followed up for at least 3 months. Patients where consent was obtained.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients whose consent was not obtained. Patients without cervical disc replacement of either MOBIC or M6C.

Study design
Purpose
Duration
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
6/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5999 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 13421 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293858 0
Self funded/Unfunded
Name [1] 293858 0
Country [1] 293858 0
Primary sponsor type
Individual
Name
my pham
Address
Suite 7a, level 7
Prince of Wales Private Hospital
Barker street,
Randwick NSW 2031, Australia
Country
Australia
Secondary sponsor category [1] 292688 0
None
Name [1] 292688 0
Not applicable
Address [1] 292688 0
Not applicable
Country [1] 292688 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 295282 0
South Eastern Sydney Local Health District Human Research Ethics Committee.
Ethics committee address [1] 295282 0
Prince of Wales Hospital
G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Enter via Edmund Blacket courtyard
Cnr High and Avoca Street Randwick NSW 2031
Ethics committee country [1] 295282 0
Australia
Date submitted for ethics approval [1] 295282 0
18/06/2016
Approval date [1] 295282 0
Ethics approval number [1] 295282 0

Summary
Brief summary
This study aims to compare the range of movement (neck moving forward/backwards) provided by two of the most common cervical disc replacements: MOBIC, M6C artifical discs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66758 0
Dr Ralph Mobbs
Address 66758 0
Suite 7a, level 7
Prince of Wales Private Hospital
Barker street,
Randwick NSW 2031, Australia
Country 66758 0
Australia
Phone 66758 0
+61 2 9650-4766
Fax 66758 0
Email 66758 0
[email protected]
Contact person for public queries
Name 66759 0
Dr My Pham
Address 66759 0
Suite 7a, level 7
Prince of Wales Private Hospital
Barker street,
Randwick NSW 2031, Australia
Country 66759 0
Australia
Phone 66759 0
+61 2 9650-4766
Fax 66759 0
Email 66759 0
[email protected]
Contact person for scientific queries
Name 66760 0
Dr My Pham
Address 66760 0
Suite 7a, level 7
Prince of Wales Private Hospital
Barker street,
Randwick NSW 2031, Australia
Country 66760 0
Australia
Phone 66760 0
+61 2 9650-4766
Fax 66760 0
Email 66760 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4615Study results articleYes Pham M, Phan K, Teng I, Mobbs RJ. Comparative Stud... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparative Study Between M6-C and Mobi-C Cervical Artificial Disc Replacement: Biomechanical Outcomes and Comparison with Normative Data.2018https://dx.doi.org/10.1111/os.12376
N.B. These documents automatically identified may not have been verified by the study sponsor.