Condition category
Musculoskeletal Diseases
Date applied
17/11/2015
Date assigned
04/07/2020
Last edited
07/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Although shoulder replacement is a well-accepted procedure for patients with pain due to arthritis, one of the common problems is loosening of the replacement part from the bone. This loosening is often seen on x-ray as a line between the bone and replacement component.
One problem of using x-ray to identify the loosening is that such lines are often seen on the first x-ray taken after the operation and their significance, therefore, remains uncertain. In addition measurements of such lines is very difficult and subjective.
A recently developed method of recording bone changes after replacement surgery involves implanting metal beads (tantalum beads) into bony areas during surgery that can later be seen using x-ray (known as radiostereometry). The 3 dimensional pattern of the beads is used to define each bone segment on radiographs, with far more accuracy than is achievable using bone outline. Using x-rays taken over time, 3-dimensional measurement of the movement of the different parts of the joint replacement relative to the bone is possible. Radiosterometry is now routinely used in early testing of hip and knee replacements with normal movement patterns identified for both successful and failing implants.
There are only a few studies of shoulder replacement using radiostereometry and we wish to expand current knowledge and begin to define normal movement in bone for the components of shoulder replacement. The aim of this study is to use radiostereometry to examine the fixation and any movement that occurs of a shoulder replacement and compare this with standard x-ray measures and clinical success.

Who can participate?
All patients undergoing shoulder replacement for primary osteoarthritis who fulfil inclusion and exclusion criteria

What does the study involve?
Patients undergoing Shoulder replacement will have tantalum beads inserted into their humerus and scapula at the time of their surgery. These beads when visualised on stereo radiographs using a technique called Radiostereometry (RSA) allow the movement of the implant in the bead marked bone over time or under load to be measured. Postoperatively in addition to routine review and completion of measures at one and two years, they will undergo a series of RSA examinations of the shoulder at fixed time points. In addition to static RSA examinations from the time of surgery, loaded examinations will be carried out in the later stages of recovery to examine motion of the bone and replacement components.

What are the possible benefits and risks of participating?
Possible benefits: Symptomatic patients post shoulder replacement will have RSA migration data available to their surgeons which may help in diagnosis of any problems
Risks:
1. Implantation of Beads: Implantation of tantalum beads during joint replacement is a well-established technique with no reported complications despite their use for almost 40 years. The additional operative time is short and tantalum is biologically inert.
2. Additional radiation exposure: These patients will require additional radiation exposure for RSA radiographs. The exposure is relatively small and a risk assessment has been performed as minor.

Where is the study run from?
Aberdeen Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
June 2010 to February 2021

Who is funding the study?
Mathys Orthopaedics Ltd (UK)

Who is the main contact?
Mr G. Patrick Ashcroft, g.p.ashcroft@abdn.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr George Ashcroft

ORCID ID

Contact details

Aberdeen University Medical School
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
+44 (0)1224 556357
g.p.ashcroft@abdn.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3/068/11, IRAS 085853

Study information

Scientific title

Radiostereometry of glenoid movement following shoulder replacement for osteoarthritis

Acronym

Study hypothesis

The aim of this study is to provide standard RSA migration data for glenoid component of shoulder replacement and increase knowledge of migration in shoulder replacement.

Ethics approval

Approved 14/09/2016, North of Scotland Research Ethics Service (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; nosres@nhs.net), ref: 11/NS/0032

Study design

Single centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Osteoarthritis of the shoulder

Intervention

Following enrolment patient will have routine shoulder radiographs carried out and complete patient related outcome measures (PROMS) prior to attending for shoulder replacement. The replacement is carried out using a standard surgical protocol with the exception of the addition of the insertion of tantalum beads in the bone. Prior to discharge patients will have further routine radiographs and their index RSA radiographs performed. Patients are then reviewed at 6 weeks, 3 months, 6 months, one year and two years. At all time points further RSA radiographs are taken, with further PROMS completed at one and two years. Additional standard radiographs are taken at 1 year. Patients will complete 2 years of post-surgery follow up.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Migration of glenoid component over 3 years measured with radiosteremetry at 6 weeks, 3 months, 6 months, 1, 2, and 3 years

Secondary outcome measures

1. Quality of life measured using the EQ5D, Constant Score at 1, 2, 3 years
2. Radiolucent lines measured using standard x-ray at 2 years

Overall trial start date

01/06/2010

Overall trial end date

02/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary shoulder replacement
2. Primary diagnosis of osteoarthritis
3. Aged between 50 and 75 years old

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Total final enrolment

15

Participant exclusion criteria

1. Inflammatory arthritis of the shoulder
2. Previous surgery of the operative shoulder
3. Renal transplant
4. Any metabolic bone disorder
5. The contra-lateral shoulder already included in the study
6. History of active joint sepsis
7. Recent high dose systemic corticosteroids
8. Primary or secondary carcinoma in last 5 years
9. Neurological disease (e.g. Parkinson's disease)
10. Psycho-social disorders that would limit rehabilitation
11. Use of bone graft, disorders of other joints in either arm that could impair rehabilitation or function

Recruitment start date

17/11/2015

Recruitment end date

04/04/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aberdeen Royal Infirmary
Aberdeen
AB25 2ZN
United Kingdom

Sponsor information

Organisation

University of Aberdeen

Sponsor details

Clinical Research Governance
Research and Development Office
Foresterhill House Annexe
Foresterhill
Aberdeen
AB25 2ZB
United Kingdom
+44 (0)1224 551123
researchgovernance@abdn.ac.uk

Sponsor type

University/education

Website

http://www.abdn.ac.uk/

Funders

Funder type

Industry

Funder name

Mathys Orthopaedics Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Early data will be presented at national and international conferences. We intend publishing the final results of the different elements trial in a number of high-impact peer-reviewed journals.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/06/2021

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/08/2020: Uploaded protocol (not peer reviewed) Version 1.6 01 March 2015. 12/06/2020: Trial’s existence confirmed by North of Scotland Research Ethics Service.