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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]

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

Rotator cuff injury

Subacromial impingement/bursitis

acromioclavicular joint osteoarthritis

shoulder instability/labral tear

Knee Arthrosopcy

ACL injury

Hip arthroscopy

Femoral Acetabular impingement and labral tear

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

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]

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]

Intra-articular fluid temperature

Timepoint [1]

During arthroscopic surgery:
- measurements will be recorded intra-operatively via use of independent sterile temperature probe

Secondary outcome [1]

Duration of surgery

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4812 - Pimlico

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Orthopaedic Research Institute (ORIQL)

Address [1]

Suite 3 Level 2
Mater Medical Centre
21-29 Fulham Rd
Pimlico 4812 Qld

Country [1]

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]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Hospital Townsville Ethics Committee

Ethics committee address [1]

Mater Hospital Townsville
21-37 Fulham Rd 
Pimlico QLD 4810

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/05/2013

Approval date [1]

23/08/2013

Ethics approval number [1]

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

Dr Matthew Wilkinson

Address

The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61747553564

Fax

research_coordinator@oriql.com.au

Contact person for public queries

Name

Andrea Grant

Address

The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61413685331

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Matthew Wilkinson

Address

The Orthopaedic Research Institute of Queensland Suite 3 Level 2 Mater Medical Centre 21-29 Fulham Rd Pimlico 4812 Qld

Country

Australia

Phone

+61747799902

Fax

research_coordinator@oriql.com.au

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

Source	Title	Year of Publication	DOI
Embase	In Vivo Arthroscopic Temperatures: A Comparison Between 2 Types of Radiofrequency Ablation Systems in Arthroscopic Anterior Cruciate Ligament Reconstruction-A Randomized Controlled Trial.	2017	https://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.

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Documents added manually

Documents added automatically