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}  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


}  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