Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000569707
Ethics application status
Approved
Date submitted
9/05/2013
Date registered
20/05/2013
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
In Vivo Arthroscopic Temperatures: Comparison between Two Types of Radiofrequency Ablation Systems
Scientific title
In individuals undergoing shoulder, hip and knee arthroscopy, how does the use of ArthroCare 'Coblation technology' ablation system compare to the regular diathermy ablation system effect in the intra-articular fluid temperatures during arthroscopy?
Secondary ID [1] 282480 0
Australia Online Forms for Research AU/1/F58217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Arthroscopy
 289107 0
Rotator cuff injury
 289131 0
Subacromial impingement/bursitis
 289132 0
acromioclavicular joint osteoarthritis
 289133 0
shoulder instability/labral tear 289134 0
Knee Arthrosopcy
 289135 0
ACL injury
 289136 0
Hip arthroscopy 294742 0
Femoral Acetabular impingement and labral tear 294743 0
Condition category
Condition code
Musculoskeletal 289445 289445 0 0
Other muscular and skeletal disorders
Surgery 289472 289472 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One group will comprise of patients undergoing arthroscopy using the ArthroCare ablation system ('Coblation') which uses radiofrequency energy to excite electrodes in the surrounding saline solution to produce a charged plasma gas that breaks down molecular bonds in tissue. Coblation system uses radiofrequency that range from 100-500 kHz. The duration of the surgery is very variable depending on the type of surgery and severity of condition.
Intervention code [1] 287129 0
Treatment: Devices
Comparator / control treatment
This group will comprise of patients undergoing arthroscopy using the Stryker ablation system which uses radiofrequency energy to create heat at the tip of the wand to ablate the targeted tissue. The radiofrequency output waveform is set at 200kHz. Again, the duration of surgery is highly variable.
Control group
Active

Outcomes
Primary outcome [1] 289549 0
Intra-articular fluid temperature
Timepoint [1] 289549 0
During arthroscopic surgery:
- measurements will be recorded intra-operatively via use of independent sterile temperature probe
Secondary outcome [1] 302711 0
Duration of surgery
Timepoint [1] 302711 0
Calculated intra-operatively

Eligibility
Key inclusion criteria
1) Clinically indicated for shoulder arthrosopcy:
- rotator cuff repair
- sub-acromial decompression, acromioplasty
- acromioclavicular joint excision
- shoulder stabilisation or labral repair
2) Clinically indicated for knee arthroscopy
- ACL reconstruction
3) Hip arhtroscopy for femoral acetabular impingement
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
<18 years of age

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be identified from those referred to participating orthopaedic surgeons for treatment of their knee or shoulder condition as per the inclusion criteria. Participants will be give a verbal and written explanation of the trial and written informed consent will be obtained. Participants will be randomised to the two groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online random number generator. Blinded allocation. Concealment will be achieved via central randomisation computer.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2014
Actual
7/03/2014
Date of last participant enrolment
Anticipated
Actual
12/06/2016
Date of last data collection
Anticipated
Actual
26/07/2016
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 980 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 6875 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 287259 0
Charities/Societies/Foundations
Name [1] 287259 0
Orthopaedic Research Institute (ORIQL)
Country [1] 287259 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
ORIQL (Orthopaedic Research Institute of Queensland)
Address
Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld
Country
Australia
Secondary sponsor category [1] 286013 0
None
Name [1] 286013 0
N/A
Address [1] 286013 0
N/A
Country [1] 286013 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289240 0
Mater Hospital Townsville Ethics Committee
Ethics committee address [1] 289240 0
Mater Hospital Townsville
21-37 Fulham Rd
Pimlico QLD 4810
Ethics committee country [1] 289240 0
Australia
Date submitted for ethics approval [1] 289240 0
09/05/2013
Approval date [1] 289240 0
23/08/2013
Ethics approval number [1] 289240 0
MHS20130806-02

Summary
Brief summary
Radiofrequency ablation is a commonly utilized tool in arthroscopic orthopaedic surgery primarily in joints such as shoulders and knees. It allows accurate debridement of soft tissues and control of bleeding. Use of radiofrequency ablation wands produces heat either directly or as a by-product. Studies have shown that if these temperatures exceed a certain threshold, (commonly known to be 45 degrees Celcius), the risk of injury to surrounding tissues within the joint is increases. We will be comparing two types of radiofrequency ablation systems that are very widely used today in arthroscopic surgery. One system, such as the Striker SERFAS Energy probe, uses radiofrequency energy to generate heat at the tip of the instrument. This heat is used to ablate or remove unwanted or damaged tissues and may also be used to coagulate vessels to control bleeding. The other system, such as that used in the Arthrocare RF wands, uses 'coblation' technology. This technology differs in that it uses radiofrequency energy to produce a controlled non-heat driven process where it excites electrodes within the surrounding saline solution to create a charged plasma gas that breaks up molecular bonds within tissue. Heat in this system, is produced as a by-product, and as claimed by its manufacturers, at much lower temperatures.

In this study we will be comparing the temperatures established in arthroscopic surgery to determine the risk of injury to surrounding tissues using both these two systems. We will be recruiting 80 patients undergoing arthroscopic knee or shoulder surgery for a variety of conditions. The patients will be randomised to the ablation system and temperatures will be continuously monitored and recorded using an independent digital temperature probe. The probe will be placed in the same location within the joint in all patients through a small key-hole incision. The duration of surgery will also be recorded. Many variable can affect the fluid temperatures and these incluced, baseline infused fluid temperature, flow rate, and number of ports. We will not be regulating these variables in order to create a more natural clinical scenario which will in turn produce results that are more relevant to the common orthopaedic surgeon.

Results will be analysed to determine the average and maximum temperatures reached in both systems, and in different types of surgeries (e.g. rotator cuff repair, sub-acromial decompression and acromioplasty, and stabilisation in shoulders, and ACL reconstruction in knees). Statistical analyses will be used to determine if there are any statistically significant differences in results using the two types of ablation systems and whether in fact using the Arthrocare charged plasma 'coblation' process will produce lower and potentially safer temperatures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39930 0
Dr Matthew Wilkinson
Address 39930 0
The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39930 0
Australia
Phone 39930 0
+61747553564
Fax 39930 0
Email 39930 0
[email protected]
Contact person for public queries
Name 39931 0
Andrea Grant
Address 39931 0
The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39931 0
Australia
Phone 39931 0
+61413685331
Fax 39931 0
Email 39931 0
[email protected]
Contact person for scientific queries
Name 39932 0
Matthew Wilkinson
Address 39932 0
The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld
Country 39932 0
Australia
Phone 39932 0
+61747799902
Fax 39932 0
Email 39932 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIn Vivo Arthroscopic Temperatures: A Comparison Between 2 Types of Radiofrequency Ablation Systems in Arthroscopic Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Trial.2017https://dx.doi.org/10.1016/j.arthro.2016.05.026
N.B. These documents automatically identified may not have been verified by the study sponsor.