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Aims. Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. Methods. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 121 - 123
1 Feb 2019
Robinson AHN Johnson-Lynn SE Humphrey JA Haddad FS


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 321 - 328
1 Feb 2021
Vandeputte F Vanbiervliet J Sarac C Driesen R Corten K

Aims

Optimal exposure through the direct anterior approach (DAA) for total hip arthroplasty (THA) conducted on a regular operating theatre table is achieved with a standardized capsular releasing sequence in which the anterior capsule can be preserved or resected. We hypothesized that clinical outcomes and implant positioning would not be different in case a capsular sparing (CS) technique would be compared to capsular resection (CR).

Methods

In this prospective trial, 219 hips in 190 patients were randomized to either the CS (n = 104) or CR (n = 115) cohort. In the CS cohort, a medial based anterior flap was created and sutured back in place at the end of the procedure. The anterior capsule was resected in the CR cohort. Primary outcome was defined as the difference in patient-reported outcome measures (PROMs) after one year. PROMs (Harris Hip Score (HHS), Hip disability and Osteoarthritis Outcome Score (HOOS), and Short Form 36 Item Health Survey (SF-36)) were collected preoperatively and one year postoperatively. Radiological parameters were analyzed to assess implant positioning and implant ingrowth. Adverse events were monitored.


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1158 - 1166
14 Sep 2020
Kaptein BL den Hollander P Thomassen B Fiocco M Nelissen RGHH

Aims

The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs).

Methods

A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 136 - 143
1 Feb 2024
van der Lelij TJN Marang-van de Mheen PJ Kaptein BL Koster LA Ljung P Nelissen RGHH Toksvig-Larsen S

Aims

The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface.

Methods

Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up.


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1087 - 1093
1 Aug 2018
Barenius B Inngul C Alagic Z Enocson A

Aims

The aim of this study was to compare the functional and radiological outcomes in patients with a displaced fracture of the hip who were treated with a cemented or a cementless femoral stem.

Patients and Methods

A four-year follow-up of a randomized controlled study included 141 patients who underwent surgery for a displaced femoral neck fracture. Patients were randomized to receive either a cemented (n = 67) or a cementless (n = 74) stem at hemiarthroplasty (HA; n = 83) or total hip arthroplasty (THA; n = 58).


The Bone & Joint Journal
Vol. 105-B, Issue 1 | Pages 72 - 81
1 Jan 2023
Stake IK Ræder BW Gregersen MG Molund M Wang J Madsen JE Husebye EE

Aims

The aim of this study was to compare the functional and radiological outcomes and the complication rate after nail and plate fixation of unstable fractures of the ankle in elderly patients.

Methods

In this multicentre study, 120 patients aged ≥ 60 years with an acute unstable AO/OTA type 44-B fracture of the ankle were randomized to fixation with either a nail or a plate and followed for 24 months after surgery. The primary outcome measure was the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score. Secondary outcome measures were the Manchester-Oxford Foot Questionnaire, the Olerud and Molander Ankle score, the EuroQol five-dimension questionnaire, a visual analogue score for pain, complications, the quality of reduction of the fracture, nonunion, and the development of osteoarthritis.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1016 - 1024
1 Aug 2020
Hasan S van Hamersveld KT Marang-van de Mheen PJ Kaptein BL Nelissen RGHH Toksvig-Larsen S

Aims

Although bone cement is the primary mode of fixation in total knee arthroplasty (TKA), cementless fixation is gaining interest as it has the potential of achieving lasting biological fixation. By 3D printing an implant, highly porous structures can be manufactured, promoting osseointegration into the implant to prevent aseptic loosening. This study compares the migration of cementless, 3D-printed TKA to cemented TKA of a similar design up to two years of follow-up using radiostereometric analysis (RSA) known for its ability to predict aseptic loosening.

Methods

A total of 72 patients were randomized to either cementless 3D-printed or a cemented cruciate retaining TKA. RSA and clinical scores were evaluated at baseline and postoperatively at three, 12, and 24 months. A mixed model was used to analyze the repeated measurements.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 117 - 124
1 Jan 2020
MacDessi SJ Griffiths-Jones W Chen DB Griffiths-Jones S Wood JA Diwan AD Harris IA

Aims

It is unknown whether kinematic alignment (KA) objectively improves knee balance in total knee arthroplasty (TKA), despite this being the biomechanical rationale for its use. This study aimed to determine whether restoring the constitutional alignment using a restrictive KA protocol resulted in better quantitative knee balance than mechanical alignment (MA).

Methods

We conducted a randomized superiority trial comparing patients undergoing TKA assigned to KA within a restrictive safe zone or MA. Optimal knee balance was defined as an intercompartmental pressure difference (ICPD) of 15 psi or less using a pressure sensor. The primary endpoint was the mean intraoperative ICPD at 10° of flexion prior to knee balancing. Secondary outcomes included balance at 45° and 90°, requirements for balancing procedures, and presence of tibiofemoral lift-off.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1392 - 1401
1 Nov 2019
Petrou S Parker B Masters J Achten J Bruce J Lamb SE Parsons N Costa ML

Aims

The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb.

Patients and Methods

An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation.


Aims

The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs).

Methods

A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1025 - 1032
1 Aug 2020
Hampton M Mansoor J Getty J Sutton PM

Aims

Total knee arthroplasty is an established treatment for knee osteoarthritis with excellent long-term results, but there remains controversy about the role of uncemented prostheses. We present the long-term results of a randomized trial comparing an uncemented tantalum metal tibial component with a conventional cemented component of the same implant design.

Methods

Patients under the age of 70 years with symptomatic osteoarthritis of the knee were randomized to receive either an uncemented tantalum metal tibial monoblock component or a standard cemented modular component. The mean age at time of recruitment to the study was 63 years (50 to 70), 46 (51.1%) knees were in male patients, and the mean body mass index was 30.4 kg/m2 (21 to 36). The same cruciate retaining total knee system was used in both groups. All patients received an uncemented femoral component and no patients had their patella resurfaced. Patient outcomes were assessed preoperatively and postoperatively using the modified Oxford Knee Score, Knee Society Score, and 12-Item Short-Form Health Survey questionnaire (SF-12) score. Radiographs were analyzed using the American Knee Society Radiograph Evaluation score. Operative complications, reoperations, or revision surgery were recorded. A total of 90 knees were randomized and at last review 77 knees were assessed. In all, 11 patients had died and two were lost to follow-up.


Aims

The aim of this study was to compare the mid-term patient-reported outcome, bone remodelling, and migration of a short stem (Collum Femoris Preserving; CFP) with a conventional uncemented stem (Corail).

Methods

Of 81 patients who were initially enrolled, 71 were available at five years’ follow-up. The outcomes at two years have previously been reported. The primary outcome measure was the clinical result assessed using the Oxford Hip Score (OHS). Secondary outcomes were the migration of the stem, measured using radiostereometric analysis (RSA), change of bone mineral density (BMD) around the stem, the development of radiolucent lines, and additional patient-reported outcome measures (PROMs).


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 440 - 441
1 Mar 2021
Nikolaou VS Masouros P Floros T Chronopoulos E Skertsou M Babis GC


Aims

Patient-specific instrumentation of total knee arthroplasty (TKA) is a technique permitting the targeting of individual kinematic alignment, but deviation from a neutral mechanical axis may have implications on implant fixation and therefore survivorship. The primary objective of this randomized controlled study was to compare the fixation of tibial components implanted with patient-specific instrumentation targeting kinematic alignment (KA+PSI) versus components placed using computer-assisted surgery targeting neutral mechanical alignment (MA+CAS). Tibial component migration measured by radiostereometric analysis was the primary outcome measure (compared longitudinally between groups and to published acceptable thresholds). Secondary outcome measures were inducible displacement after one year and patient-reported outcome measures (PROMS) over two years. The secondary objective was to assess the relationship between alignment and both tibial component migration and inducible displacement.

Patients and Methods

A total of 47 patients due to undergo TKA were randomized to KA+PSI (n = 24) or MA+CAS (n = 23). In the KA+PSI group, there were 16 female and eight male patients with a mean age of 64 years (sd 8). In the MA+CAS group, there were 17 female and six male patients with a mean age of 63 years (sd 7). Surgery was performed using cemented, cruciate-retaining Triathlon total knees with patellar resurfacing, and patients were followed up for two years. The effect of alignment on tibial component migration and inducible displacement was analyzed irrespective of study group.


The Bone & Joint Journal
Vol. 100-B, Issue 3 | Pages 296 - 302
1 Mar 2018
Sprowson† AP Jensen C Parsons N Partington P Emmerson K Carluke I Asaad S Pratt R Muller S Ahmed I Reed MR

Aims

Surgical site infection (SSI) is a common complication of surgery with an incidence of about 1% in the United Kingdom. Sutures can lead to the development of a SSI, as micro-organisms can colonize the suture as it is implanted. Triclosan-coated sutures, being antimicrobical, were developed to reduce the rate of SSI. Our aim was to assess whether triclosan-coated sutures cause a reduction in SSIs following arthroplasty of the hip and knee.

Patients and Methods

This two-arm, parallel, double-blinded study involved 2546 patients undergoing elective total hip (THA) and total knee arthroplasty (TKA) at three hospitals. A total of 1323 were quasi-randomized to a standard suture group, and 1223 being quasi-randomized to the triclosan-coated suture group. The primary endpoint was the rate of SSI at 30 days postoperatively.


Bone & Joint 360
Vol. 12, Issue 1 | Pages 26 - 29
1 Feb 2023

The February 2023 Wrist & Hand Roundup. 360. looks at: ‘Self-care’ protocol for minimally displaced distal radius fractures; Treatment strategies for acute Seymour fractures in children and adolescents: including crushed open fractures; Routinely collected outcomes of proximal row carpectomy; Moving minor hand surgeries in the office-based procedure room: a population-based trend analysis; A comparison between robotic-assisted scaphoid screw fixation and a freehand technique for acute scaphoid fracture: a randomized, controlled trial; Factors associated with conversion to surgical release after a steroid injection in patients with a trigger finger; Two modern total wrist arthroplasties: a randomized comparison; Triangular fibrocartilage complex suture repair reliable even in ulnar styloid nonunion


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 247 - 255
1 Feb 2021
Hassellund SS Williksen JH Laane MM Pripp A Rosales CP Karlsen Ø Madsen JE Frihagen F

Aims

To compare operative and nonoperative treatment for displaced distal radius fractures in patients aged over 65 years.

Methods

A total of 100 patients were randomized in this non-inferiority trial, comparing cast immobilization with operation with a volar locking plate. Patients with displaced AO/OTA A and C fractures were eligible if one of the following were found after initial closed reduction: 1) dorsal angulation > 10°; 2) ulnar variance > 3 mm; or 3) intra-articular step-off > 2 mm. Primary outcome measure was the abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) after 12 months. Secondary outcome measures were the Patient-Rated Wrist and Hand Evaluation (PRWHE), EuroQol-5 dimensions 5-level questionnaire (EQ-5D-5L), range of motion (ROM), grip strength, “satisfaction with wrist function” (score 0 to 10), and complications.


The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 98 - 104
1 Jan 2021
van Ooij B Sierevelt IN van der Vis HM Hoornenborg D Haverkamp D

Aims. For many designs of total knee arthroplasty (TKA) it remains unclear whether cemented or uncemented fixation provides optimal long-term survival. The main limitation in most studies is a retrospective or non-comparative study design. The same is true for comparative trials looking only at the survival rate as extensive sample sizes are needed to detect true differences in fixation and durability. Studies using radiostereometric analysis (RSA) techniques have shown to be highly predictive in detecting late occurring aseptic loosening at an early stage. To investigate the difference in predicted long-term survival between cemented, uncemented, and hybrid fixation of TKA, we performed a randomized controlled trial using RSA. Methods. A total of 105 patients were randomized into three groups (cemented, uncemented, and hybrid fixation of the ACS Mobile Bearing (ACS MB) knee system, implantcast). RSA examinations were performed on the first day after surgery and at scheduled follow-up visits at three months, six months, one year, and two years postoperatively. Patient-reported outcome measures (PROMs) were obtained preoperatively and after two years follow-up. Patients and follow-up investigators were blinded for the result of randomization. Results. RSA secondary stabilization did not show a significant difference between the three types of fixation. A maximum total point motion of less than 0.2 mm in the second postoperative year was shown in each group, which suggests stabilization of the implant. At 24 months after surgery, PROMs significantly improved compared to baseline in all treatment groups. No significant difference was observed between the three groups. Conclusion. Secondary stabilization measurements in this study demonstrated no significant difference between the groups. In all groups migration stabilized after initial settling of the implant. For this implant the long-term outcome is not expected to be influenced by the type of fixation to the bone. Cite this article: Bone Joint J 2021;103-B(1):98–104