1. LIMA SMR RCT
} 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
2. LIMA AXIOMA TT Cohort study
} 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
3. Orthospace RCT
} 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
4. SHeRPA RCT
} 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
5. Zimmer-BIOMET PRP Study
} 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
6. Hand-1 Study
} 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
o Aged over 18 years
o One or more fingers with a Dupuytren’s contracture of >30º in the MCPJ and/or PIPJ
o Well defined cords causing contracture
o No previous Dupuytren’s surgery or NF to the same hand
o Willing to undergo either study procedure
o Able to complete follow up assessments
} Exclusion criteria
o Dupuytren’s contracture of the DIPJ only
o Planned dermofasciectomy or very limited fasciectomy (excision of 1cm cord segment)
o Previously recruited into this study for treatment of either hand
o 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:
o To record the number and proportion of a) patients assessed for eligibility; b)eligible patients who consent; c) consented patients that are randomised
o To assess the willingness of surgeons to recruit patients with different patterns of Dupuytren’s contracture
o To assess the adherence by surgeons and patients with the allocated treatment
o To examine the completion of follow up assessments
o To assess and optimise the recruitment process and patient pathway using an integrated qualitative research component
o To identify the appropriate primary outcomes for the main trial