Title: Radiosteriometric analysis (RSA) of the stability of metal-backed glenoid components in total shoulder arthroplasty
Randomised controlled trial comparing two versions of the LIMA SMR metal-backed glenoid component, one of which is coated with hydroxyapatite (HA)
Patients listed for anatomical shoulder replacement with LIMA SMR component can be considered for inclusion
Eligible patients are randomised at the time of surgery to receive either the HA or non-HA coated version of the component
Surgery is performed in a standard fashion, however study patients also have 4-5 tantalum beads inserted in/around the glenoid during surgery
RSA X-Rays taken at 3/12, 6/12, 12/12 and 24/12
RSA X-Rays analysed using refined computer system which can accurately detect even minimal migration of the implant (as little as 0.2mm)
CT scan taken pre-op and at approximately 24/12 post-op
PROMs (ASES, Oxford shoulder score, Quick Dash), Constant score and ROM also recorded pre-op and again at 3/12, 6/12, 12/12 and 24/12
Recruitment still ongoing
Title: Radiostereometric analysis of the stability of metal-backed glenoid components in total shoulder arthroplasty
Non-randomised, longitudinal study designed to assess the implant stability of, and the clinical outcomes of patients fitted with, the LIMA AXIOMA TT glenoid component
Newer version of the LIMA metal-backed glenoid component involving a modular peg system composed of trabecular titanium
Patients listed for shoulder replacement surgery (including revision and reverse operations) can be considered for inclusion
RSA protocol identical to the aforementioned RCT
CT scans taken pre-op, 6/12 and 24/12
PROMs (same as RCT) Constant score and ROM recorded pre-op, then again at 6/12, 12/12 and 24/12 post-operatively
Title:
‘A randomised, two-arm, prospective, subject blind study to assess the safety and efficacy of the Inspace device in comparison to full thickness massive rotator cuff repair, in subjects scheduled for a repair surgery’
The Inspace device is a sub-acromial spacer device made of a biodegradable co-polymer of lactide acid and epsilon-caprolactone
The device is inserted (uninflated) using a specially designed introducer, then inflated with saline once appropriately situated in the sub-acromial space
Participants are randomised in theatre, once it has been established that a complete repair of the tear is not possible
Main inclusion criteria:
Aged 40 years or over
Positive diagnostic imaging of the affected shoulder (MRI within 9/12 of consent date) indicating full thickness massive rotator cuff tear of at least 5cm in diameter or long narrow tears of at least 4cm2 (W >2cm and L > 2cm) involving more than one tendon
Pain for >3/12 with failure to respond to conservative management
Able to comply with protocol procedures
Willing to undergo video/photographic documentation of the affected shoulder
Signed informed consent
Main exclusion criteria:
Known allergy to device material
Tears of less than 5cm diameter or that can be fully repaired
Evidence of severe OA, arthropathy or cartilage damage of the shoulder seen on MRI or during surgery
Evidence of gleno-humeral instability
Previous shoulder surgery within 12/12
Evidence of major trauma, infection or necrosis of the shoulder
Partial thickness tear only
‘Major medical condition that may affect quality of life and influence the results of the study e.g. HIV, uncontrolled diabetes, active malignancy in the past 5 years, acute MI, CVA etc’
Known drug or alcohol abuses
Individuals with ongoing litigation claims in relation to the shoulder injury
Females of childbearing potential who are pregnant, breastfeeding or plan to become pregnant during the course of the study
Concurrent participation in any other study
The presence of any implanted devices that would contraindicate undergoing an MRI
Claustrophobia that would inhibit ability to undergo MRI
Patient follow-up
Recording of outcomes pre-operatively and then at 3/52, 3/12, 6/12, 12/12, and 24/12
MRI imaging at 12/12 post-operatively
Clinical assessment of the shoulder and Constant score at each f/u
PROMs: Quick Dash, ASES, WORC, EQ-5D-5L at each f/u
Recording of any adverse events at each f/u
Recording of pain medications required at each f/u
Title: Shoulder Hemiarthroplasty or Reverse Polarity Arthroplasty for Trauma (SHeRPA) Study
Prospective, multicentre, randomised trial comparing hemi-arthroplasty against reverse polarity arthroplasty for the management of proximal humeral fractures
Patients with acute (<3/52) 3 or 4 part proximal humeral fracture diagnosed on plain X-Ray should be considered for inclusion
Patients randomised in theatre to receive one of the above procedures
Follow up takes place at 6/52, 3/12, 12/12 and 24/12
Inclusion criteria:
Consenting patients 65 years and over
Acute (i.e. < 3 weeks) 3 or 4 part proximal humeral fracture diagnosed on plain radiograph
Patient suitable for surgical intervention
Un-reconstructable fracture as determined at the time of surgery
Exclusion criteria:
Dementia
Refusal of consent
Patient unsuitable for reverse polarity arthroplasty
Glenoid fracture
Axillary nerve injury
Pre-existing serious condition of the affected side which severely affects the movement of the shoulder e.g. CVA, brachial plexus injury, Congenital problem
Main pre-operative interventions:
Standardised radiographic series including: AP view, Transthoracic scapula ‘Y’ view and modified axial view
CT scan
PROMs (Quick DASH, Oxford shoulder score, ASES and EQ-5D)
Main post-operative interventions:
Standardised radiographic series: AP views in neutral and 30º external rotation, Transthoracic scapula ‘Y’ view and Axillary view
Constant Score
PROMs as above
Pain VAS and Satisfaction VAS
NB. Primary outcome is the difference in the mean constant score at 12/12 post-operatively
Title: ‘Post-market data collection for chronic lateral epicondylitis patients treated with leukocyte and platelet-rich plasma (L-PRP) prepared with the Recover mini platelet separation kit’
Single-arm, multicentre, observational study
Aim of study is to characterise the performance of L-PRP and to explore the impact of patient demographics and baseline characteristics on treatment outcome.
Secondary aim is to document the healthcare utilisation and associated costs for those treated with L-PRP
Inclusion Criteria
Willing to give signed consent
Male or female of 18 years or over
Confirmed diagnosis of unilateral chronic LE
Duration of LE symptoms of 3 months or longer
Failed at least one previous LE treatment (including wait and see, physiotherapy, analgesics, NSAID’s steroid injection, bracing etc)
Exclusion Criteria
No active systemic inflammatory condition
No active leukemia or metastatic malignant cells
No current chemotherapy treatments
No pregnancy
No lactation
No infected tendons, skin infection or skin disease in the area of the injection site
Participating in any other drug or device study
Follow-ups will take place at 3/12, 6/12, 12/12, 24/12 and 36/12
Patients can receive up to 3 L-PRP injections, but f/u will be time indexed to the initial injection
Follow up will continue until the patient completes the 36/12 follow-up period or another invasive treatment (e.g. steroid injection, surgery etc.) is received
Outcomes of interest
Occurrence of adverse events
No. of patients who reach resolution of chronic LE symptoms
Change in pain measured with NRS
Change in arm function measured with Quick DASH
Change in QOL measured with EQ-5D-3L
Cost associated with healthcare measured by assignment of a unit cost to each reported resource utilisation
No. of patients receiving more than 1 L-PRP injection
Title: Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers: a feasibility study which investigates the acceptability and design of a multicentre randomised controlled trial
NIHR-funded feasibility study
Chief investigator: Professor Tim Davis, Nottingham University hospitals NHS Trust
Recruitment sites: Nottingham, Derby and Wrightington
Currently recruitment at this site is from Professor Murali’s clinic only
Inclusion criteria
Aged over 18 years
One or more fingers with a Dupuytren’s contracture of >30º in the MCPJ and/or PIPJ
Well defined cords causing contracture
No previous Dupuytren’s surgery or NF to the same hand
Willing to undergo either study procedure
Able to complete follow up assessments
Exclusion criteria
Dupuytren’s contracture of the DIPJ only
Planned dermofasciectomy or very limited fasciectomy (excision of 1cm cord segment)
Previously recruited into this study for treatment of either hand
Life expectancy of less than 3 years
This study has been designed to inform the design of a large-scale, multicentre RCT to assess the clinical and cost effectiveness of NF versus LF for the treatment of Dupuytren’s contracture
Main objectives of the study:
To record the number and proportion of a) patients assessed for eligibility; b)eligible patients who consent; c) consented patients that are randomised
To assess the willingness of surgeons to recruit patients with different patterns of Dupuytren’s contracture
To assess the adherence by surgeons and patients with the allocated treatment
To examine the completion of follow up assessments
To assess and optimise the recruitment process and patient pathway using an integrated qualitative research component
To identify the appropriate primary outcomes for the main trial