Clavicle Trial Emily Tims Research Physiotherapist Royal Free Hospital THE CLAVICLE TRIAL

Content History of trial Clavicle fracture patient journey Paperwork THE CLAVICLE TRIAL

Background To operate or not to operate? (Felder-Puig et al.; 2010)

History of trial Idea for trial Recruitment begins Ethical approval Research Physio starts NIHR Portfolio New trial sites BESS Bupa Foundation Protocol submission to ‘Trials’ for publication

SeptDec R & D Approval for Ipswich and Warwick DecMarJune Protocol published in ‘Trials’ journal R & D Approval for Leicester and Torbay Approached other sites for involvement in study: Medway KCH Southampton Poole Watford Luton Portsmouth Maistone Brighton Mar Trial Day

Update January JulyDecember TRIAL DAY Amendment 6 New sites opened: Poole, Kings, Watford, Luton, Medway Southampton, Porstmouth, Maidstone New sites awaiting R&D approval: Brighton Extra Bupa Foundation funding agreed

Luton Watford Royal Free University College St Thomas’ St George’s Bart’s KCH Medway Maidstone Sites Leicester Coventry Ipswich North Bristol Yeovil District Torbay Poole Southampton Portsmouth Brighton

The journey of a Clavicle Trial patient THE CLAVICLE TRIAL

Where our patients come from

1 2 3

% 69% 28%

1 2 3

THE CLAVICLE TRIAL

“In the type-2B subgroup there was no residual contact between the major fragments and variable degrees of shortening which was usually apparent both clinically and radiologically. Two further subgroups of type-2B were simple or wedge comminuted fractures (type 2B1) and isolated segmental or segmentally comminuted fractures (type 2B2).” Robinson 1998 Robinson description

THE CLAVICLE TRIAL Flowchart

INCLUSION CRITERIAEXCLUSION CRITERIA  Age years  Patient refusal  Midshaft fracture of clavicle  Medically unfit (ASA grd 4-5)  Robinson Classification 2B1 and 2B2 Diplaced midshaft fracture  All other clavicle fractures  Associated ipsilateral fracture  Medically fit (ASA grd 1-3)  Established non-union from previous fracture  Factors that may influence bone healing or pre-injury function of the upper limb (previous fractures/operations around clavicle, metabolic bone disease, significant neuro-musc upper limb disability)

THE CLAVICLE TRIAL

6 weeks, 3 months and 9 months: Constant and DASH score 3 month x-ray copy to main site (unless previously united on x-ray) Follow-ups

THE CLAVICLE TRIAL

30 questions where subject rates level of difficulty doing functional activity30 questions where subject rates level of difficulty doing functional activity Scores 0-100Scores Extra work and sports modules.Extra work and sports modules. Good reliability and validity (Beaton et al., 2001; Gummeson et al., 2003)Good reliability and validity (Beaton et al., 2001; Gummeson et al., 2003)

Questions?

References Beaton et al Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. Journal of Hand Therapy, 14 (2): Beaton et al Measuring the whole or the parts? Validity, reliability, and responsiveness of the Disabilities of the Arm, Shoulder and Hand outcome measure in different regions of the upper extremity. Journal of Hand Therapy, 14 (2): Conboy et al An Evaluation of the Constant-Murley Assessment. Journal of Bone and Joint Surgery, 78: B.Conboy et al An Evaluation of the Constant-Murley Assessment. Journal of Bone and Joint Surgery, 78: B. Gummesson, C; Atroshi, I; Ekdahl, C The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery, BMC Musculoskeletal Disorders, 4: 11.Gummesson, C; Atroshi, I; Ekdahl, C The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery, BMC Musculoskeletal Disorders, 4: 11.

Robinson, C. 1998: Fractures of the clavicle in the adult. Epidemiology and classification. J 390 Bone Joint Surg Br 80(3): Robinson, C. 1998: Fractures of the clavicle in the adult. Epidemiology and classification. J 390 Bone Joint Surg Br 80(3): Felder-Puig R, Mathis S, Pelinka H, Mittermayr T, Pieske O, [Midshaft clavicle fractures : A systematic review of different treatment approaches.]. Der Unfallchirurg 2010 Jul [Epub ahead of print] PMID: Felder-Puig R, Mathis S, Pelinka H, Mittermayr T, Pieske O, [Midshaft clavicle fractures : A systematic review of different treatment approaches.]. Der Unfallchirurg 2010 Jul [Epub ahead of print] PMID: