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
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
- ISRCTN49912293_PROTOCOL_v1.6_01Mar2015.pdf uploaded 07/08/2020