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Bone & Joint Open
Vol. 6, Issue 2 | Pages 195 - 205
14 Feb 2025
Selim A Dass D Govilkar S Brown AJ Bonde S Burston B Thomas G

Aims. The conversion of previous hip fracture surgery to total hip arthroplasty (CTHA) can be surgically challenging with unpredictable outcomes; reported complication rates vary significantly. This study aimed to establish the medium-term survival and outcomes of CTHA performed following a previous hip fracture surgery. Methods. All CTHAs performed at our tertiary orthopaedic institution between January 2008 and January 2020 following previous ipsilateral hip fracture surgery were included. Patients were followed up clinically using Oxford Hip Scores (OHS), and radiologically until death or revision surgery. Postoperative complications, radiological implant failure, and indications for revision surgery were reviewed. Results. A total of 166 patients (167 hips) were included in the study, with a mean age of 71 years (42 to 99). Of these, 113 patients (67.7%) were female. CTHA followed cannulated screw fixation in 75 cases, hemiarthroplasty in 18, dynamic hip screw fixation in 47, and cephalomedullary nail in 27 cases. Patients were followed up for a mean of four years (0.1 to 9.3). During the follow-up period, 32 patients (19.2%) died. Overall, 14 patients (8.4%) suffered a complication of surgery, with intraoperative fractures (4.2%) and dislocations (3.6%) predominating. The survival probability was 96% at 9.53 years in the cemented group and 88% at 9.42 years in the uncemented group (p = 0.317). The median OHS improved from 13 (IQR 7.75 to 21.25) preoperatively to 39 (IQR 31 to 45) postoperatively in the uncemented group, and from 14 (IQR 10.5 to 22) to 38 (IQR 27 to 45) in the cemented group. Conclusion. This study highlights that CTHA from hip fracture surgery is associated with higher complication rates than conventional THA, but good medium-term results can be achieved. Their classification within the NJR requires review, acknowledging the increased potential for complications. Cite this article: Bone Jt Open 2025;6(2):195–205


Bone & Joint Open
Vol. 6, Issue 2 | Pages 186 - 194
13 Feb 2025
Battaglia AG D'Apolito R Ding BTK Tonolini S Ramazzotti J Zagra L

Aims

Revision hip arthroplasty for femoral stem loosening remains challenging due to significant bone loss and deformities requiring specialized revision stems. The aim of this study was to evaluate the clinical and radiological outcomes, and survival, of a consecutive series of femoral revisions performed using a primary cementless stem with tapered geometry and rectangular cross-section at medium-term follow-up.

Methods

We retrospectively evaluated 113 patients (115 hips) with intraoperative Paprosky type I (n = 86) or II (n = 29) defects, who underwent femoral revision with Alloclassic Zweymüller SL stem for one-stage aseptic revision or two-stage septic revision from January 2011 to December 2020. The mean follow-up was 77.9 months (SD 33.8). Nine patients were lost to follow-up (deceased or not available), leaving 104 patients (106 hips) for the clinical and radiological analysis. Clinical assessment was performed with Harris Hip Score (HHS) and visual analogue scale (VAS) before surgery and at final follow-up.


Orthopaedic Proceedings
Vol. 107-B, Issue SUPP_1 | Pages 8 - 8
10 Feb 2025
Aamir J Kumar RM Ali M Abdullah BS McEvoy J Wyatt C Pillai A Mason L
Full Access

Background. Medial wall blowout (MWB) ankle fractures have not previously been described in the literature. Our aim in this study was to analyse the morphology of medial wall blowout fractures and their radiological outcomes. Methods. The MWB fracture fragments were characterised into four groups. A type 1A fracture was described as an anteromedial column fragmentation. Type 1B fractures consisted of posteromedial column fragmentation. Type 2 fracture consisted of both column wall fragmentation and type 3, any medial wall fragmentation with medial joint impaction. Results. Over 2000 patients were identified across ten years with medial malleolar fractures across two centres; of these, 196 had MWB fractures with CT imaging. There were 95 1A fractures (48.5%), 31 1B fractures (15.8%), 40 Type 2 fractures (20.4%) and 30 type 3 fractures (15.3%). Type 1B fractures were significantly more likely to undergo plate fixation than other types (p = .001). MWB fractures occurred most in PER fracture types (50.8%). Type 2 fractures were different because they occurred more with SER-type mechanisms. PM fractures were a common association (82.4%), most commonly M+M type 1. MWB type 1B occurred more with M+M 2B fractures. The overall malreduction rate was 11.8%, although 1B fracture types had significantly higher malreductions (22.6%, p=.041). The overall nonunion rate was 20.6%, the highest nonunion reported in the type 2 fractures (33.3%), although not significant. Tibialis posterior tendon entrapment was common (47.3%), although it was significantly more likely in type 2 fractures (74.4%, p = 0.001). Conclusion. The MWB fractures are an uninvestigated subtype of ankle fractures. The 1B type has a higher rate of malreduction, which could be due to its higher association with PM fractures. Tib post needs specific attention with these fracture types, especially Type 2 fractures


Orthopaedic Proceedings
Vol. 107-B, Issue SUPP_1 | Pages 11 - 11
10 Feb 2025
Ali SA Mubark I Weerasinghe K
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The aim was to demonstrate that Supramalleolar osteotomy is a valuable treatment method in eccentric ankle arthritis in young and middle aged since it is an under-utilised procedure. We retrospectively analysed the outcome of it performed over 12 year period. We also compared the results of recently introduced computer-assisted PSI Integrated custom-made implants with standard implants. Data was analysed from 48 patients over a period of 12 years of which 40 were by standard implant and 8 by computer assisted custom implant. 31 varus, 18 valgus deformity. The mean age was 57 (26–79 y/o), male:female ratio was 27:19. Mean follow-up was 15.25 months for standard implants; For the computer-assisted procedures the follow up range is 24 to 2 months. TAS, TTS and TT angels were measured pre and post-operatively. Fixation using a plate with/without bone graft or custom-made implant was performed by a single surgeon. MOXFQ and AOFAS questionnaires were completed pre and post-operatively. All followed similar rehabilitation programme. Average radiological healing time was 24.3 weeks. MOXFQ score improved from 55.17 to 25.11 and AOFAS from 20.16 to 56.21. Complications were 2 non-unions, 1 delayed union, 1 stress fracture. 8 patients require fusion/replacement between 3–5 years. The PSI Integrated computer-assisted technique gave improved accuracy than standard freehand method with better scores and a smoother approach for the surgeon. Early results with this technique are encouraging as we were able achieve 3 dimentional correction compared to the 2 dimentional correction achieved by the freehand method. Our results are comparable to similar studies. Being a joint preserving technique, Supra Malleolar Osteotomy should be considered either as an interim or definitive procedure especially with the development of computer assisted technologies which makes the technique easier to reproduce


Orthopaedic Proceedings
Vol. 107-B, Issue SUPP_1 | Pages 16 - 16
10 Feb 2025
Lorchan T Newton A Ray R Chua MJ Murphy E Lam P
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Background. Hallux Valgus (HV) is a common forefoot deformity that can cause pain and difficulty with walking. There are a range of surgical techniques to treat HV deformity, but there is a risk of recurrence. This paper reviews the clinical assessment and management of recurrent HV as well as a detailed description of how percutaneous surgical techniques can be used to treat recurrent HV. This paper identifies technical challenges of percutaneous HV surgery for recurrent HV deformity as well as strategies to address and mitigate these. Method. This was a multicenter retrospective review of adult patients who had recurrent hallux valgus deformity (defined as hallux valgus angle&gt;15° and having previously undergone primary surgical intervention for HV deformity correction) who were treated with a percutaneous metatarsal extra-capsular transverse osteotomy (META) technique, with at least one year of follow-up data. Demographic information, hallux valgus angle, intermetatarsal angle, Manchester-Oxford Foot Questionnaire (MOXFQ), visual analog scale (VAS), and EQ-5D-5L scores were collected. Results. We retrospectively evaluated 34 feet from 32 patients with a mean age of 63.1±9.2 (range 41–82) who underwent revision hallux valgus surgery using a percutaneous technique. The mean follow up was 3.6±2.3 (range 0.5–8.7 years. The breakdown of index HV surgeries was: 17 Chevron, 9 Scarf/Akin, 6 medial bunionectomy, 1 Lapidus, 1 proximal rotation osteotomy. There was a statistically significant improvement in both clinical foot function and radiographic deformity after surgery. The mean HV angle decreased from 32.9±8.6° to 13.4±7.3°, and the intermetatarsal angle decreased from 12.7±3.8° degrees to 3.8±3.1°(p<0.05). The mean MOXFQ Index score significantly improved from 49.4±23.1 to 14.6±19.4 (p<0.05). Conclusion. This paper suggests that percutaneous surgical techniques using a transverse osteotomy and screw fixation can successfully treat a wide range of recurrent HV deformity severities with significant improvement in clinical and radiographic outcomes


Orthopaedic Proceedings
Vol. 107-B, Issue SUPP_1 | Pages 15 - 15
10 Feb 2025
Townsend O Hill N Reaney A Koç T Lewis T Gordon D
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Introduction. Minimally invasive (percutaneous) distal first metatarsal osteotomy with internal fixation is an established technique for hallux valgus deformity correction. Published data is limited to 2–3 years follow-up. This study aimed to assess patients undergoing MICA (Minimally Invasive Chevron and Akin) with minimum 5-year follow up, to evaluate the longer-term results of this procedure using validated patient reported outcome measures (PROMs). Methods. Five-year PROM data was prospectively collected from 117 patients who underwent 169 primary MICA osteotomies between July 2014 and April 2018, performed by a single surgeon. Primary clinical outcome measures included visual analogue scale for pain (VAS-pain), Manchester-Oxford Foot Questionnaire (MOXFQ) and EuroQol-5 Dimensions Index (EQ-5D). Data were collected preoperatively, at 2 years and after a minimum of 5 years. Statistical significance was set at p< 0.05. Results. 169 MICA were performed on 117 patients (112 females, 5 males). Mean follow-up was 6.7 years (standard deviation (SD) 0.96 years). All patients completed minimum 5-year follow-up scores. The MOXFQ scores (mean ± SD) for all 169 feet improved for all domains: from 44.5 ± 22.1 preoperatively to 10.3 ± 17.0 post-operatively for Pain (p<0.001), from 39.2 ± 24.5 to 9.3 ± 17.9 for Walking and Standing (p<0.001) and from 48.2 ± 22.8 to 8.7 ± 17.6 for Social Interaction (p<0.001). VAS-pain improved from 30.8 ± 22.7 to 12.9 ± 21. (p<0.001). EQ-5D Index improved from 0.74 ± 0.14 to 0.90 ± 0.12 (p<0.001). Conclusion. This is the largest study at this time point presenting PROM data following minimally invasive distal first metatarsal osteotomy. It is also the longest in follow up for this technique. This study demonstrates significant improvement in PROMs at the mid-term and MICA can be considered as an effective and long-lasting option for the management of hallux valgus deformity


Bone & Joint Research
Vol. 14, Issue 2 | Pages 97 - 110
6 Feb 2025
Zhang D Zhu T Bai J Chen C Wen J Zhou Y Guan X

Aims

In our previous research, we have found that melatonin (MEL) affects the osteoporotic process. By balancing bone remoulding, autophagy is involved in age-related bone loss. However, as a regulator of autophagy, whether MEL influences senile osteoporosis via regulating autophagy remains unclear.

Methods

Cellular, radiological, and histopathological evaluations were performed on 36 16-month-old male C57BL6/L mice or aged bone marrow-derived mesenchymal stem cells. A MEL-gelatin methacrylamide system was constructed to aid osteoporotic fracture healing.


Bone & Joint Research
Vol. 14, Issue 2 | Pages 77 - 92
4 Feb 2025
Spanninga BJ Hoelen TA Johnson S Cheng B Blokhuis TJ Willems PC Arts JJC

Aims

Autologous bone graft (ABG) is considered the ‘gold standard’ among graft materials for bone regeneration. However, complications including limited availability, donor site morbidity, and deterioration of regenerative capacity over time have been reported. P-15 is a synthetic peptide that mimics the cell binding domain of Type-I collagen. This peptide stimulates new bone formation by enhancing osteogenic cell attachment, proliferation, and differentiation. The objective of this study was to conduct a systematic literature review to determine the clinical efficacy and safety of P-15 peptide in bone regeneration throughout the skeletal system.

Methods

PubMed, Embase, Web of Science, and Cochrane Library were searched for relevant articles on 13 May 2023. The systematic review was reported according to the PRISMA guidelines. Two reviewers independently screened and assessed the identified articles. Quality assessment was conducted using the methodological index for non-randomized studies and the risk of bias assessment tool for randomized controlled trials.


Bone & Joint 360
Vol. 14, Issue 1 | Pages 15 - 18
1 Feb 2025

The February 2025 Hip & Pelvis Roundup360 looks at: Postoperative periprosthetic femoral fractures after hip arthroplasty: quantifying the other half of the picture; Hip arthroscopy in patients with borderline dysplasia: how do we know when it will not work?; The morbidly obese patient remains a challenge for arthroplasty surgeons; Unexpected positive cultures in aseptic revision hip and knee arthroplasty: does it make a difference?; Failed spinal anaesthesia in hip and knee arthroplasty surgery; Clinical failure of femoral neck fracture is associated with varus necks; Navigating the angles: how variations in femoral and acetabular versions influence hip pain and treatment; High-tech or hands-on? Similar outcomes in direct anterior total hip arthroplasty.


Bone & Joint 360
Vol. 14, Issue 1 | Pages 36 - 39
1 Feb 2025

The February 2025 Trauma Roundup. 360. looks at: Risk factors for nonunion in femoral neck fracture patients with internal fixation: a multicentre (TRON group) retrospective study; Tranexamic acid administered at time of hospital admission does not decrease transfusion rates or blood loss for extracapsular hip fractures; The effect of anterior support screw (AS2) in unstable femoral trochanteric fractures; The effect of coronal plane angulation on patient-reported outcome measures of operatively treated distal femur fractures; Do proximal humerus fractures treated nonoperatively benefit from supervised physiotherapy?; Cephalomedullary nails: are dual lag screws superior to single lag screws?; Does cement need to be pressurized for hemiarthroplasty?


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 239 - 245
1 Feb 2025
Evenhuis RE Bus MPA van Nes J Walter SG Cabrolier J Fiocco M van der Wal RJP Broekhuis D Sellevold S van de Sande MAJ

Aims

Over time, the locking mechanism of Modular Universal Tumour and Revision System (MUTARS) knee arthroplasties changed from polyethylene (PE) to polyether-ether-ketone Optima (PEEK) and metal-on-metal (MoM) in an attempt to reduce the risk of mechanical failure. In this study, we aimed to assess the cumulative incidence of locking mechanism revision for symptomatic instability by type of material, and assess potential associated risk factors.

Methods

The MUTARS Orthopaedic Registry Europe was used for a retrospective review of 316 patients (54% male (n = 170), median age 44 years (IQR 23 to 61)) who underwent a MUTARS knee arthroplasty for oncological indications between December 1995 and January 2023. The minimum follow-up was 12 months, and the median follow-up was 7.9 years (IQR 3.3 to 13.0). A competing risk model was used to estimate the cumulative incidence of first locking mechanism revision with death and revision for any other reason as competing events. Possible risk factors were assessed employing a univariate cause-specific hazards regression model.


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 221 - 228
1 Feb 2025
Graham SM Masterson S Laubscher M Ferreira N Harrison WJ Simpson AHRW Maqungo S

Aims. HIV and musculoskeletal injuries both disproportionately affect individuals living in low- and middle-income countries (LMICs), leading to a significant number of fractures in HIV-positive patients. Despite this, little is known about the long-term outcomes for these patients. This prospective cohort study investigated whether HIV infection is associated with fracture-related infections (FRIs). Methods. All adult patients between September 2017 and December 2018 who received intramedullary nail fixation of lower limb fractures in two tertiary referral hospitals in Cape Town, South Africa, were deemed eligible. In total, 358 participants were recruited for this study, 33 of whom were lost to follow-up. Of the 325 participants, 37 (11.4%) developed a total of 39 FRIs over the study period; 25 were early FRIs (64.1%) and 14 were late FRIs (35.9%). Participants were followed up for a minimum of 24 months. Throughout follow-up, participants were monitored for FRIs. These were categorized as early FRIs (< 90 days) and late FRIs (> 90 days). Results. Overall, 71 participants (21.8%) were HIV-positive and 254 participants were HIV-negative (78.2%). In the HIV-positive population, 15 participants (21.1%) suffered 16 FRIs: seven early FRIs (9.9%) and nine late FRIs (7.0%). In the HIV-negative population, 22 participants (8.7%) experienced 23 FRIs, 18 were early FRIs (7.1%), and five participants experienced late FRIs (2.0%). On univariate and multivariate regression, being HIV-positive increased a participant’s likelihood of suffering late FRIs, and FRIs overall. HIV status made no significant difference to early FRI rates. Conclusion. Contrary to recent evidence, this study demonstrates an association between HIV and an increased risk of a patient developing late FRIs. However, there was no significant difference in early FRI rates. Cite this article: Bone Joint J 2025;107-B(2):221–228


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 139 - 148
1 Feb 2025
Goh EL Khatri A Costa AB Ting A Steiner K Png ME Metcalfe D Cook JA Costa ML

Aims. Older adults with hip fractures are at high risk of experiencing complications after surgery, but estimates of the rate of specific complications vary by study design and follow-up period. The aim of this systematic review was to determine the prevalence of complications in older adults after hip fracture surgery. Methods. MEDLINE, Embase, CINAHL, and CENTRAL databases were searched from inception until 30 June 2023. Studies were included if they reported prevalence data of complications in an unselected, consecutive population of older adults (aged ≥ 60 years) undergoing hip fracture surgery. Results. A total of 95 studies representing 2,521,300 patients were included. For surgery-specific complications, the 30-day prevalence of reoperation was 2.31%, surgical site infection 1.69%, and deep surgical site infection 0.98%; the 365-day prevalence of prosthesis dislocation was 1.11%, fixation failure 1.77%, and periprosthetic or peri-implant fracture 2.23%. For general complications, the 30-day prevalence of acute kidney injury was 1.21%, blood transfusion 25.55%, cerebrovascular accident 0.79%, lower respiratory tract infection 4.08%, myocardial infarction 1.98%, urinary tract infection 7.01%, and venous thromboembolism 2.15%. Conclusion. Complications are prevalent in older adults who have had surgery for a hip fracture. Studies reporting complications after hip fracture surgery varied widely in terms of quality, and we advocate for the routine monitoring of complications in registries and clinical trials to improve the quality of evidence. Cite this article: Bone Joint J 2025;107-B(2):139–148


Bone & Joint 360
Vol. 14, Issue 1 | Pages 48 - 49
1 Feb 2025
Marson BA

In this edition of Cochrane Corner, two updated reviews have been published in the Cochrane database. The first is a very broad review of rehabilitation strategies for patients with ankle fractures and includes early mobilization, the use of removable splints, and physical therapy techniques for patients treated with and without surgery. The second evaluates interventions for fixing tibial plateau fractures, including fixation techniques and bone graft substitutes


Bone & Joint 360
Vol. 14, Issue 1 | Pages 42 - 46
1 Feb 2025

The February 2025 Children’s orthopaedics Roundup360 looks at: Are antibiotics enough for the initial management of paediatric Gustilo-Anderson type I upper limb open fractures?; Advanced imaging for tibial tubercle fractures; Spinal fusion improves quality of life in cerebral palsy scoliosis: a multicentre study; Hip displacement after triradiate closure in ambulatory cerebral palsy; Telehealth validation for adolescent idiopathic scoliosis: comparable clinical measurements enhance access to care; Long-term prognostic markers for residual dysplasia in developmental dysplasia of the hip after closed reduction; Open versus closed reduction for paediatric lateral humeral condyle fractures: better outcomes with closed techniques; Delayed diagnosis of paediatric septic hip leads to poor outcomes and doubling of healthcare costs.


Bone & Joint 360
Vol. 14, Issue 1 | Pages 26 - 29
1 Feb 2025

The February 2025 Wrist & Hand Roundup. 360. looks at: Delayed fixation of distal radial fractures beyond three weeks increases the odds of reoperation; A systematic review of management options for symptomatic scaphometacarpal impingement after trapeziectomy; Diagnosing occult scaphoid fractures: an art or science?; Dual-mobility trapeziometacarpal arthroplasty shows promising outcomes but lacks long-term evidence; 3D-printed titanium scaphoid implant offers a promising alternative for unreconstructable scaphoid nonunion; Lidocaine co-injection reduces pain intensity during corticosteroid injections in hand and wrist conditions; Long-term outcomes of PyroDisk arthroplasty for trapeziometacarpal osteoarthritis; Evaluating the impact of COVID-19 on hand surgery practices: adaptations and missed opportunities


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 181 - 187
1 Feb 2025
Barret H Tiercelin J Godenèche A Charousset C Audebert S Lefebvre Y Gallinet D Barth J Bonnevialle N

Aims

Loosening of the glenoid component in the long term remains an important complication of the anatomical total shoulder arthroplasty (aTSA). The aim of this study was to explore the bony integration of a hybrid glenoid component based on an analysis of CT scans.

Methods

In a prospective multicentre study, patients who underwent primary aTSA, whose hybrid design of glenoid component included a fully-polyethylene flanged upper peg and a porous-coated titanium lower peg, and who were reviewed with CT scans between 12 and 24 months postoperatively, were included. Two independent observers reviewed the scans. Bony integration of the upper peg was scored as described by Arnold et al, and integration of the lower peg was scored as described by Gulotta et al. Perforation of the glenoid vault in any plane was also assessed.


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 193 - 203
1 Feb 2025
Groven RVM Mert Ü Greven J Horst K Joris V Bini L Poeze M Blokhuis TJ Huber-Lang M Hildebrand F van Griensven M

Aims

The aims of this study, using a porcine model of multiple trauma, were to investigate the expression of microRNAs at the fracture site, in the fracture haematoma (fxH) and in the fractured bone, compared with a remote unfractured long bone, to characterize the patterns of expression of circulating microRNAs in plasma, and identify and validate messenger RNA (mRNA) targets of the microRNAs.

Methods

Two multiple trauma treatment strategies were compared: early total care (ETC) and damage control orthopaedics (DCO). For this study, fxH, fractured bone, unfractured control bone, plasma, lung, and liver samples were harvested. MicroRNAs were analyzed using quantitative real-time polymerase chain reaction arrays, and the identified mRNA targets were validated in vivo in the bone, fxH, lung, and liver tissue.


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 164 - 172
1 Feb 2025
Popa C Le Baron M Dobelle É Flecher X Prost S Ollivier M Argenson J Jacquet C

Aims

The aim of this study was to assess the necessity of revising the acetabular component in revision total hip arthroplasty (THA) in patients with a Vancouver type B2 periprosthetic femoral fracture (PFF) who require revision of the femoral component. The hypothesis was that revision of both the acetabular and femoral components and using a dual-mobility acetabular component would provide a lower postoperative risk of dislocation, without increasing perioperative morbidity and mortality.

Methods

Data were retrospectively analyzed from a continuously gathered database. We included 150 revisions, performed between January 2015 and December 2022, in 150 patients, with 81 revisions limited to only the femoral component and 69 involving revision of both components. This resulted, after surgery, in 60 patients having a simple-mobility acetabular component and 90 having a dual-mobility component. The mean age of the patients was 79.7 years (SD 10.1), and 98 were female (65.3%). The mean follow-up was 31 months (SD 2.3).


The Bone & Joint Journal
Vol. 107-B, Issue 2 | Pages 229 - 238
1 Feb 2025
Webster J Goldacre R Lane JCE Mafham M Campbell MK Johansen A Griffin XL

Aims

The aim of this study was to evaluate the suitability, against an accepted international standard, of a linked hip fracture registry and routinely collected administrative dataset in England to embed and deliver randomized controlled trials (RCTs).

Methods

First, a bespoke cohort of individuals sustaining hip fractures between 2011 and 2016 was generated from the National Hip Fracture Database (NHFD) and linked to individual Hospital Episode Statistics (HES) records and mortality data. Second, in order to explore the availability and distribution of outcomes available in linked HES-Office of National Statistics (ONS) data, a more contemporary cohort with incident hip fracture was identified within HES between January 2014 and December 2018. Distributions of the outcomes within the HES-ONS dataset were reported using standard statistical summaries; descriptive characteristics of the NHFD and linked HES-ONS dataset were reported in line with the Clinical Trials Transformation Initiative recommendations for registry-enabled trials.