Condition category
Musculoskeletal Diseases
Date applied
30/06/2017
Date assigned
14/07/2017
Last edited
06/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Osteoarthritis is a condition that causes joints to become painful and stiff. Hip osteoarthritis can be treated with hip replacement surgery, where the damaged hip joint is replaced with an artificial implant. The surgeon has various choices as to which implant they use. The implant that surgeons routinely use comes in two different lengths: the original (150mm) length or the ‘short’ (125mm) length. It is not known whether patient outcomes differ based on the length of the implant used. The aim of this study is to find out whether the length of the hip replacement stem has any influence on pain and physical function after total hip replacement.

Who can participate?
Patients aged 45-80 undergoing total hip replacement for osteoarthritis

What does the study involve?
Participants are randomly allocated to receive either an ‘original’ (150mm) or ‘short’ (125mm) stem as part of routine total hip replacement at the study centre. Hip function, quality of life, pain, joint awareness, satisfaction and implant position are measured at the start of the study and after 1 and 2 years.

What are the possible benefits and risks of participating?
It is thought that the length of stem does not affect patient recovery or outcomes after surgery in any way. Participants do not directly benefit from taking part in this study, but the knowledge gained may benefit other people by helping to find the best way to treat people who need total hip replacement in the future. Both stem lengths are available for routine use in the study centres, and as such there are no additional risks in taking part in this study beyond those of having routine total hip replacement surgery.

Where is the study run from?
1. Royal Infirmary of Edinburgh (UK)
2. Golden Jubilee National Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
Stryker (USA)

Who is the main contact?
Dr David Hamilton
d.f.hamilton@ed.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Hamilton

ORCID ID

http://orcid.org/0000-0001-9060-9255

Contact details

Chancellor's Building
49 Little France Crescent
Edinburgh
EH16 4SB
United Kingdom
+44 (0)131 242 6301
d.f.hamilton@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2 (01-04-16)

Study information

Scientific title

Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomised controlled equivalence trial of 125mm vs 150mm Exeter stems in total hip arthroplasty

Acronym

CASINO

Study hypothesis

That the use of the 125mm ExeterTM stem in routine total hip arthroplasty achieves equivalent short-term (up to 2 years post-op) patient-reported and radiographic outcomes as the 150mm Exeter stem.

Ethics approval

South East Scotland Research Ethics Committee 02, 12/05/2017, ref:16/SS/0176

Study design

Multi-centre prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not currently available in web format, please use contact details to request a participant information sheet

Condition

Hip osteoarthritis

Intervention

Patients will be randomised on a 1:1 ratio to receive either an ‘original’ (150mm) or ‘short’ (125mm) ExeterTM stem as part of routine total hip arthroplasty at the study centre. Randomisation will be by computer generated number, stratified by centre using random block sizes.

A standard operative technique will be employed by all trial surgeons; using the posterior approach, ExeterTM femoral component and ContemporaryTM acetabular component (Stryker). All implants will be cemented. The routine post-operative patient care protocol of the study centre will be employed.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Patient reported function, measured using the Oxford Hip Score at baseline, 1 year and 2 years

Secondary outcome measures

1. Quality of life, measured using the EQ5D-5L questionnaire at baseline, 1 year and 2 years
2. Pain, measured using the visual analogue scale at baseline, 1 year and 2 years
3. Joint awareness, measured using the Forgotten Joint Score-12 at baseline, 1 year and 2 years
4. Satisfaction, measured using a satisfaction Likert response scale at 1 and 2 years
5. Radiographic implant position, measured using AP pelvis radiographs at 1 year

Overall trial start date

01/01/2016

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Planned total hip replacement for osteoarthritis
2. Planned primary hip arthroplasty with standard implants
3. Patients aged 45-80
4. Patient willing and able to comply to the study protocol

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

1. Dysplasia of the hip/acetabulum
2. Requirement for acetabular bone grafting
3. Planned bilateral procedures within the trial period
4. Activity-limiting pain in either knee or contralateral hip
5. Procedures done for pain relief (such as for patients with no walking capacity)
6. Already recruited to the trial

Recruitment start date

01/06/2017

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Golden Jubilee National Hospital
Glasgow
G81 4DY
United Kingdom

Sponsor information

Organisation

ACCORD; The University of Edinburgh & NHS Lothian

Sponsor details

The Queen’s Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

Industry

Website

http://www.accord.scot/

Funders

Funder type

Industry

Funder name

Stryker

Alternative name(s)

Stryker Corporation

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Publication of trial results will be sought through high-ranked peer reviewed speciality journals with an expectation of publication 1 year following the end of the last patient follow-up.

IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes