Study	Reason for exclusion
ACTRN12610000730000	This trial, formerly listed as ongoing, intended to compare minimally invasive versus standard open reduction of proximal humeral fractures. The trial was not recruiting, nor had ethics approval been applied for, at time of registration (2 September 2010). The trial registration has not been updated and we received no response to our request on 31 January 2020 for clarification of the trial status from Mr Jeremy Stanley, Auckland, New Zealand. Inspection of the current interests of Mr Stanley indicate that he has a special interest in sports injuries. We anticipate that this trial was abandoned and may not have started.
Arias‐Buria 2015	This RCT investigated the inclusion of trigger point dry needling in a multimodal physical therapy programme for postoperative shoulder pain. Mixed population; 15 participants had a proximal humeral fracture. However, the single duration intervention was given 5 months post‐surgery. Ineligible participant population. (Also, very short term follow‐up.)
Avci 2013	This study investigated two different surgical drilling techniques. An online translation of the Turkish article indicates that participants "were divided into two groups according to the surgical technique used to determine and send the screw length." Not an RCT.
Bai 2014	Online translation indicates this was a “retrospective case analysis” evaluating the lateral deltoid‐splitting approach for treating proximal humeral fractures. Not an RCT.
Bai 2015	Online translation indicates the participants with proximal humeral fractures “were divided into two groups according to the internal fixation protocol”. Not an RCT.
Baudi 2014	Retrospective study that compared functional and radiographic results of reverse prosthesis versus hemiarthroplasty after complex displaced proximal humeral fractures in elderly people. Ineligible study design.
Bing 2002	This was a randomised clinical trial (sealed envelopes ‐ computer‐generated sequence ‐ held in a box), recruitment 3 November 1997 to 14 January 1999, that compared Rush pins fixation with Polaris nail fixation of displaced two‐part fractures of the proximal humerus. Contact with a Dr Sharma in July 2000 revealed 65 of the 80 participants in the trial had reached 2‐year follow‐up. Abstract by Bing et al published in 2002 indicated 40 participants, of whom 30 had been followed‐up for one year. Information gained via Alison Armstrong from Grahame Taylor (one of the authors of the Bing abstract) indicated that there were some concerns about the extent of missing data. Both groups had a high reoperation rate to remove metalware causing impingement. This trial has been excluded because of insufficient data. It seems very likely, based on location and study dates, that the trial registration, Der Tavitian 2006, formerly awaiting classification, is for this trial.
Bolano 1995	No proximal humeral fractures in a randomised trial of humeral shaft fracture treatment.
Brownson 2001	This is listed in the National Research Register as a multicentre randomised trial of the management of displaced surgical neck and displaced shaft fractures of the humerus with the Halder humeral nail. Contact with Mr Brownson revealed this to be part of the trial run from Nottingham (see Wallace 2000) which had been abandoned. Mr Brownson indicated that the very specific inclusion criteria (2‐part fractures with over 50% displacement) had reduced the potential sample size; participant consent had also been a problem.
Caforio 2017	This trial investigated the effects of an early rehabilitation program in 3‐part proximal humeral fractures treated with endomedullary nailing. Although described as randomised in the abstract, the discussion reports that a limitation of the research was that it was not a randomised controlled study.
Caliskan 2019	The discussion indicates this was a retrospective study that compared open reduction and internal fixation with non‐operative management for proximal humeral fractures. Ineligible study design.
Carbone 2012	This is a prospective comparison of MIROS (Minimally Invasive Reduction and Osteosynthesis System®) versus traditional percutaneous pinning, each intervention being carried out at one of two hospitals in the same town in Italy. Not randomised.
Chapman 1997	No proximal humeral fractures in a randomised trial of humeral shaft fracture treatment.
Chen 2014	Study compared two surgical approaches for treating proximal humeral fractures. The PubMed entry indicates this is a case‐control study.
Chen 2019	Although this study ‐ testing a bespoke sling after plate fixation ‐ met the inclusion criteria for this review, it became clear after data extraction and risk of bias assessment that this poorly conducted and reported small trial had several major flaws and data issues that made the findings unreliable. We received no response to our request sent on 7 February 2020 to Zong‐Sheng Yin for further information on interventions, randomisation, loss to follow‐up and fracture type distribution. In particular, we were uncertain of the Constant scores, which were reported for day 1 pre‐op, day 3 post‐op, 30 days (primary outcome) and final follow‐up. Measurement of Constant scores (0 to 100: best outcome) at the first two times is unusual practice. The high mean scores are unusual for this population and for day 3 seem incorrect, as did the lack of progress over time at 30 days and at final follow‐up.
Chen H 2018	This is a retrospective comparison of people with displaced proximal humeral fractures treated by locking compression plate with or without fibular allograft.
Chen JL 2018	This is a retrospective comparison of two locking plates: PHILOS plate versus Zimmer Periarticular Locking Plate.
ChiCTR1900025412	This study planned to compare different interventions (PHILOS plate, hemiarthroplasty and reverse total shoulder arthroplasty) for treating 3‐ or 4‐part proximal humeral fracture in elderly people. Non‐randomised observational study.
ChiCTR‐TRC‐14004213	The objective of this unpublished study (recruitment period 2014 to 2016) was to investigate when to begin passive motion exercise after operation of old fractures of greater tuberosity. 'Old' not defined but probably surgery on healed fractures of the greater tuberosity causing post‐traumatic impingement. Ineligible study population.
Chiu 1997	No proximal humeral fractures in a quasi‐randomised trial of humeral shaft fracture treatment.
Cigni 2012	This study, published only as a conference abstract, compared two approaches for plate fixation. The abstract did not mention how the 40 participants "were divided in two groups", but we judged it was very unlikely this was through randomisation.
De Boer 2003	This is a multicentre comparative study of locked internal fixators and non‐operative treatment. Not randomised.
Dias 2001	Trial abandoned. This randomised trial (random number sheets that were remotely administered) compared hemiarthroplasty versus fixation (generally, suture reinforced with wires) versus non‐surgical treatment (manipulation, sling for 2 weeks, then mobilisation) for 3‐ and 4‐part fractures of the proximal humerus. Trial started in 2001, with one year follow‐up (outcome was assessed by independent physiotherapists). Aimed for 90 to 100 participants, aged > 45 years. Contact with Alison Armstrong revealed that recruitment stalled at 11 participants (16 refusals) in 2008; centre stopped trial when it became a trial site for the ProFHER trial.
Edelson 2008	Article mentions an abandoned randomised trial comparing "operative versus conservative care" which was unsuccessful "because patients insisted on proactively choosing rather than being assigned to a treatment group by lot"." No other details given.
Elidrissi 2013	Prospective study involving 26 participants with proximal humeral fractures treated with open reduction and internal fixation using an anatomical humeral plate (12 participants) or a palm tree pinning technique of Kapandji (14 participants). Inspection of the full text confirmed this was not a randomised or quasi‐randomised trial.
Erdoğan 2014	This study compared locking plate fixation with or without an inferomedial screw (IMS) in 36 proximal humeral fractures. Inspection of the full text showed this to be a retrospective comparison.
EUCTR 2015‐001820‐51	This randomised study evaluated the effect of implanting bone marrow‐derived mononuclear cells for bone augmentation of plate‐stabilised proximal humeral fractures. Biological intervention outside the scope of our review.
Fan 2012	Translation of this study comparing surgical versus non‐surgical treatment showed this was a retrospective comparison: "To this end, we retrospectively analyzed 2009 1 Month ‐ January 2011 35 cases".
Flannery 2006	This is listed in the National Research Register as a randomised trial comparing non‐surgical treatment and hemiarthroplasty for four‐part fractures of the proximal humerus. Contact with Mr Flannery revealed his centre failed to recruit anyone into the trial. Mr Turner, the lead investigator of the multicentre trial, involving the South Thames Shoulder and Elbow Group, confirmed that the trial was abandoned due to the inability to recruit participants.
Ge 2017	Participants were divided into a plate group (locking plates) or the nail group (intramedullary nails) at discretion of the treating physician and finally of the participant. The participants who declined surgical treatment and only agreed to receive conservative treatment constituted the conservative group. Not an RCT.
Ge 2019	Comparison of 2 types of needle therapy acting as adjuvant analgesic treatment. Intervention not in scope of review.
Gradl 2009	Prospective study involving 152 participants with unilateral displaced and unstable proximal humeral fractures treated either with an antegrade angular and sliding stable proximal interlocking nail or an angular stable plate. Not a randomised or quasi‐randomised trial.
Hems 2000	This is listed in the National Research Register as a randomised trial comparing non‐surgical treatment and the Halder humeral nail for displaced fractures of the surgical neck and shaft of the humerus. Contact with Mr Hems revealed this to be part of the trial run from Nottingham (see Wallace 2000). Mr Hems indicated that they had had considerable difficulty in recruiting participants (only those with proximal humeral fractures were eligible in his centre) and had no results.
HOMERUS	This single‐centre trial aimed to compare angle stable locking compression plate osteosynthesis versus hemiarthroplasty for three‐ and four‐part fracture of the proximal humerus in 134 older people. It was listed as ongoing in the 2015 version of the review. Contact with Prof Diercks on the status of the trial revealed that it had been abandoned: "Thank you, sorry not to have informed you but we could not reach the inclusion rate necessary for the power, so the study was stopped some years ago" (13 June 2020).
IRCT2013052313435N1	The trial registration document for this study stated that it was randomised. However, a search identified a journal publication that described "prospective clinical trial, observational ‐ Cohort studying" and gave no mention of random allocation. Hence this is not a randomised trial.
ISRCTN32335957	This was registered as a randomised study of reverse shoulder prosthesis and hemiarthroplasty for elderly people with proximal humeral fractures. However, the principal investigator left the hospital (and country) before it started and a contact at Liverpool (Matthew Smith) confirmed that the study was closed after this.
Jin 2016	This study investigated the clinical effects of the probing method with depth gauge for determining the screw depth of locking proximal humeral plate. Technical detail outside the scope of our review.
Kim 2016	Non‐randomised comparison of open reduction and plate osteosynthesis and minimally invasive plate osteosynthesis for the treatment of 2‐part proximal humeral fractures. Not an RCT.
Kim 2018	Retrospective study evaluating augmented fixation procedures: locking plate fixation and fibular allograft augmentation versus locking plate fixation and additional inferomedial screws. Ineligible study design.
Kulkarni 2000	This is listed in the National Research Register as a randomised comparison of operative and non‐operative management of proximal humeral fractures. This trial was abandoned due to poor recruitment, mainly due to lack of participant consent.
Li 2015	For a trial comparing two surgical procedures (minimally invasive versus open plate fixation), the 8‐week follow‐up is very short. The measurement of individual outcomes is either not or poorly defined. The only outcomes that we would present in the review ‐ complications ‐ are misleadingly reported and the short follow‐up means that these can be considered interim outcomes only. We have excluded this trial because we consider the flawed study design and reporting of this trial mean that it cannot and does not contribute meaningful data for the comparison
Liao 2009	While the English abstract claims that "70 senile patients" were "randomly divided into three groups to receive different surgical methods", the distribution and characteristics (age and fracture type) of the participants in the three groups indicated serious selection bias and implied this was not a randomised trial. For example: "21 patients in the group A receiving Kirschner tension band or screw internal fixation, 37 patients in group B receiving internal fixation of locking proximal humeral plate, and 12 patients in group C receiving humeral head replacement." There was no reply to request for clarification from the lead author.
Maniscalco 2014a	This was stated in the title and text of the conference abstract to be a "randomized controlled clinical trial" that compared early rehabilitation with standard rehabilitation after intramedullary nailing with a Diphos nail. However, the two groups were not concurrent and it seems that this was retrospective comparison with an historic control group. A subsequent publication of a cohort study of the nail used in this study makes no mention of this trial and adds support to our interpretation (Maniscalco 2014b). Ineligible study design.
Martetschlager 2012	The choice of intervention (deltopectoral versus anterolateral‐splitting approach for locking plate fixation) was according to surgeon's preference and not "random" as suggested by the study authors. The Discussion referred to "several limitations, including its retrospective study design" of this "current study". Hence this was not a randomised or quasi‐randomised controlled trial.
Martin 2000	Contact with a trialist revealed that, due to the discovery of problems with randomisation, it was decided not to proceed with publication as the trial results could be compromised.
Mechlenburg 2009	This was originally registered as a randomised controlled trial comparing a plate with a hemiarthroplasty. However, it is now registered as a prospective study of fixation with a PHILOS plate. Inger Mechlenburg confirmed that no participants had been included in the trial ‐ the trial was abandoned because no funding was obtained.
NCT00205959	Non‐randomised study comparing three surgical implants for proximal humeral fracture.
NCT00384852	The primary aim of this multicentre randomised trial was to "assess whether fracture union is accelerated in subjects with humeral fractures (proximal, diaphyseal) treated non‐surgically (standard of care) and a single dose of rhBMP‐2/CPM [recombinant human bone morphogenetic protein‐2 (rhBMP‐2)/Calcium Phosphate Matrix] compared to subjects who receive standard of care alone". Its results were reported in a systematic review (ref 69* in Lo 2012). This reported that "[w]hile promising, the published results from the Phase II studies for humeral and femoral fractures showed little enhancement over traditional treatments [69,70]. A positive risk/benefit ratio for these treatments was not demonstrated leading to Pfizer no longer pursuing the clinical development of rhBMP‐2/CPM for these applications." Attempts over several months to obtain the report using the citation provided always met with the claim of 'server maintenance'. Unfortunately, Kevin Lo also could not supply a copy of this article (12 February 2015) and hence the reason for exclusion. *A Phase 2, Multicenter, Double‐blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein‐2 (rhBMP‐2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus, Pfizer, Inc. Sep 15. 2011 ClinicalStudyResults.org,. http://www.clinicalstudyresults.org/documents/company‐study_11378_0.pdf
NCT00818987	This randomised controlled trial, registered in 2009, intended to compare surgery (internal fixation) versus non‐surgical treatment. Through his inspection in 2020 of the centre research records, Darren Roffey found that the study was terminated in 2013, with no record of participants being recruited.
NCT01086202	The study design for this completed study is unclear. It is labelled as an observational case‐control study but describes in the trial registration that "20 patients will be randomized to the Tornier Reversed shoulder Arthroplasty Medial offset, and 20 will receive the Lateral offset design". It has a mixed population (rotator cuff tear arthroplasty, irreparable rotator cuff tear, significant proximal humeral fracture and malunions, or chronic proximal humerus dislocation) that, in view of the small sample size, means it is unlikely to provide useful data for this review.
NCT01532076	This randomised trial, which compared adipose tissue‐derived mesenchymal stem cells composite graft augmentation versus acellular composite graft augmentation, was terminated early after recruiting only 8 of the planned 290 participants with an isolated proximal humeral fracture.
NCT01817933	This study investigated an integrated rehabilitation program for humeral neck fracture, vertebral fracture, distal radial fracture and hip fractures after surgical fixation. Not an RCT.
NCT02052206	This was originally registered as a randomised trial aiming to compare computer‐assisted 3D (3 dimensional) planning versus conventional 2D (2 dimensional) planning for shoulder replacement surgery in 80 participants with either osteoarthritis of the shoulder or complex proximal humeral fracture. However, the updated entry November 2017 indicated that it was a single intervention cohort in 20 participants. Hence it is excluded because it is not a randomised comparison.
NCT02597972	RCT investigating reverse total shoulder arthroplasty versus open reduction internal fixation. Trial was terminated after enrolling 3 participants.
NCT03017105	Trial examining cross‐education was terminated because of "very low recruitment" (Jenna Bardsley). No publication intended.
NCT03804853	RCT evaluating rehabilitation following reverse total shoulder arthroplasty in people with osteoarthritis: ineligible participant population.
NCT04285606	RCT testing short immobilisation with patient‐directed therapy versus long immobilisation with supervised therapy after reverse shoulder arthroplasty. Ineligible participant population: rotator cuff tear and osteoarthritis.
NTR2186	The registration document of this study, which compared the DePuy Delta Xtend reversed shoulder prosthesis with non‐surgical treatment in the management of 4‐part fractures of the proximal humerus, indicates this is not a randomised trial. The non‐surgical treatment arm was a historical control group.
Parnes 2005	There has been no response from the lead author of this ‘trial’ (last contact attempted 8 June 2012), which appears to have been reported in a conference abstract only. In 2003, 50 participants with 3‐ and 4‐part fractures and fracture dislocations of the proximal humerus were "random selected" for surgery (closed or open reduction and external fixation or hemiarthroplasty) or non‐surgical treatment.  The very limited results are split descriptively according to three groups (2 reflecting the 2 different surgical methods). There is currently insufficient evidence to support this being a randomised trial.
Pullen 2007	This is listed in the National Research Register Archive as a randomised trial comparing the T2 proximal humeral nail with the PHILOS plate system in participants with 2‐ or 3‐part proximal humeral fractures. The recruitment target was 100 participants (between 1 September 2005 to 1 September 2007), and follow‐up was 16 weeks. We have not located any report of this study other than the details provided in the National Research Register (UK) by, at that time, a Trauma and Orthopaedic Registrar who has now moved to another hospital. There was no response to a request for further information sent 8 June 2012. There is no indication that this study, which may not have started, will ever be reported.
Rasool 2015	This very inadequately reported and methodologically flawed trial reported range of movement results only. These results included implausible data that were inconsistently reported in the abstract. Our search for the lead author was hampered by variations in their name; the status of the institute where the research was conducted was also uncertain. We received no response to our enquiries. This trial is excluded because the very limited evidence available is invalid.
Rodriguez‐Merchan 1995	No proximal humeral fractures in a quasi‐randomised trial of humeral shaft fracture treatment.
Rollo 2019	Discussion confirmed this was a retrospective study that compared a new design of proximal humeral plate with the most‐used plates in the treatment of proximal humeral fractures. Ineligible study design.
ROTATE 2019	This trial, listed as ongoing in the 2015 version of the review, aimed to compare external rotation of the shoulder in a neutral rotation brace versus polysling holding the proximal humerus in internal rotation after extramedullary plate fixation. It was terminated after recruiting just 2 participants out of the intended 100.
Schoch 2019	Cohort study comparing uncemented versus cemented reverse shoulder arthroplasty for proximal humeral fractures. Not an RCT.
Shah 2003	This is listed in the National Research Register Archive as a multicentre randomised trial of the management of four‐part fractures of proximal humerus that compared hemiarthroplasty versus non‐surgical treatment. The recruitment target was 200 participants, with a one‐year follow‐up using the Constant‐Murley Shoulder Score and Oxford Shoulder Score. The listed start and end dates were 1 January 2003 and 1 February 2005. No details were received of the other centres in the very limited further information received from Mr Shah in April 2003. There was no response to a request for further information sent 13 November 2006. There is no indication that this study, which may not have started, will ever be reported.
Shah 2018	This study investigated the effect of desensitisation methods during the early mobilisation phase in post‐fracture conditions of the upper extremity. Ineligible participant population despite some PHFs in this mixed upper‐extremity fracture population.
Torrens 2015	Clarification was received from Carlos Torrens on 8 July 2020 that this trial, with the same comparison as Torrens 2012, reported as ongoing in the 2015 version of the review, did not in fact take place.
Wallace 2000	This is listed in the National Research Register as a multicentre randomised trial of the management of displaced surgical neck and displaced shaft fractures of the humerus with the Halder humeral nail. Contact with Prof Wallace's secretary revealed that the study had not gone ahead. The secretary mentioned three other sites (Halifax; Liverpool; and one in Scotland). No reason given. See Brownson 2001.
Wan 2005	This is a mixed population trial evaluating additional mobilisation therapy that included other fractures (e.g. clavicular and scapular fractures) as well as proximal humeral fractures. This trial was excluded because separate proximal humeral fracture data were not reported and the contact author is unavailable.
Wang 2014	The keywords describe this as a ‘case control’ study that compared swing shoulder and internal fixation in treating proximal humeral fractures. Not an RCT.
Warnecke 1999	A multicentre prospective study but not a randomised trial.
Yang 2006	Correspondence with the author revealed that this was not a randomised trial. The choice of surgery was dependent on the success of closed reduction.
You 2016	Application of 3D (3 dimensional) printing technology on the treatment of complex proximal humeral fractures. Diagnostic tool tested in a clinical setting, not really an intervention.
Zhang 2010	While the English abstract claims that "58 patients with 3 parts and 4 parts fractures of proximal humerus were randomly treated with AO locked compressive plates (LCP) or humeral head replacement", the characteristics (fracture type) of the participants in the two groups indicated serious selection bias and implied this was not a randomised trial. Thus, 25 of 28 participants in the plate group had 3‐part fractures (1 with a dislocation) and 3 had 4‐part fractures (1 with dislocation) whereas 11 of 30 in the replacement group had 3‐part fractures (2 with dislocation), 16 with 4‐part fractures (4 with dislocation) and the other three had humeral head split fractures. There was no reply to request for clarification from the lead author.
Zhao 2017	Although this study (comparing minimally invasive versus open reduction plate fixation) met the inclusion criteria for this review, it became clear after data extraction and risk of bias assessment that this poorly conducted and reported small trial had several major flaws and data issues that made the findings unreliable. The flaws included: a) an ill‐defined method of randomisation ("randomized block"); b) no account of participant flow including post‐randomisation exclusion of an unknown number of older participants because of "severe systemic diseases"; c) the ill‐defined fracture population; d) the variable and wide length of follow‐up (4 to 24 months); d) the usually high Constant‐Murley and Neer scores with usually narrow standard deviations (e.g. 1.0), especially for data collected at different follow‐up times; and the scores of over 100 (e.g. 129.4) for 36‐item Short‐Form Health Survey (SF‐36) scores (the maximum should be 100). After checking the peer‐reviewer comments in the journal, we considered that it would serve no purpose going back to get clarification.
Zhao 2019	The abstract of this study, which tested the addition of fibular allograft to locking plate fixation, reported that the participants "were randomly divided" but the Methods indicated that it was a retrospective study and the Discussion clarified that "it is not a randomized trial because the two techniques were performed at different times".

PHILOS: Proximal Humerus Internal Locking System