Session 13: DOS Best Papers

Torsdag den 24. oktober
16:30 - 18:00
Lokale:
Chairmen: Peter Toft Tengberg og Bo Sanderhoff-Olsen

103. Improved healing of diabetic foot ulcers after high-dose vitamin D: a randomized double-blinded clinical trial
Peter Max Halschou-Jensen, Jannie Sauer, Jesper Fabrin, Pierre Bouchelouche, Stig Brorson, Søren Ohrt-Nissen
Orthopaedic surgery, Herlev and Gentofte University Hospital; Orthopaedic surgery, Zealand University Hospital; Orthopaedic surgery, Zealand University Hospital; Clinical Biochemistry , Zealand University Hospital; Orthopaedic surgery, Zealand University Hospital; Orthopaedic surgery, Zealand University Hospital


Background: Chronic foot ulcers are a major cause of morbidity in diabetics with a life-time risk of chronic ulcers on the lower extremities of 25 %. Treatment is challenging and estimated 14 % have chronic leg ulcers for more than 10 years. Vitamin D deficiency is seen more commonly in diabetic patients with chronic foot ulcers, compared to non-diabetics as well as diabetics without foot ulcer.
Purpose / Aim of Study: To assess the efficacy of high-dose compared to low-dose Cholecalciferol vitamin D3 on healing of chronic diabetic foot ulcers.
Materials and Methods: We included diabetic patients with one or more ulcers of the foot for more than 6 weeks. Patients were randomly allocated to either a daily oral intake of high-dose (170 μg) or low-dose (20 μg) Cholecalciferol vitamin D3. Patients were seen in the outpatient clinic after 4, 12, 24, 36 and 48 weeks. At each visit, the ulcer was measured with a validated camera and the area (cm2) was calculated. Patients and assessors were blinded to treatment allocation. All patients were followed for 48 weeks or until wound healing or surgical treatment.
Findings / Results: 64 ulcers in 48 patients (24 in each group) were included in the analysis. 41 ulcers were followed until healing or 48-week follow-up and 20 ulcers were surgically treated during the study period. Three patients were lost to follow-up. The intention-to-treat analysis showed a significantly higher rate of ulcer healing in the high-dose group with 21/30 (70%) compared to 12/34 (35%) healed ulcers in the low-dose group (p = 0.012). Median ulcer reduction at final follow-up was 100% [IQR: 72 to 100] compared to 57% [IQR: -28 to 100.0]. Furthermore, we found a significant effect of high- dose Cholecalciferol vitamin D3 in the repeated measures analysis of variance using square-root- transformed ulcer area as dependent variable (p = 0.014).
Conclusions: High-dose Cholecalciferol vitamin D3 is efficient, compared to low-dose Cholecalciferol vitamin D3, in promoting wound healing in diabetic foot ulcers.

104. Vitamin E diffused THA liners show no less head penetration after 5 years postoperatively compared to HXLPE in a randomized controlled trial
Kristian Kjærgaard, Ming Ding, Carsten Jensen, Charles Bragdon, Henrik Malchau, Christina Møller Andreasen, Ole Ovesen, Christian Hofbauer, Søren Overgaard
Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Denmark, ; Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Denmark, ; Department of Orthopaedic Surgery, Kolding Hospital, Kolding, Denmark, Institute of Regional Health Research, University of Southern Denmark, Denmark; Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA, ; Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, MA, USA, ; Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Denmark, ; Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Denmark, ; Department of Orthopaedic Surgery, Vejle Hospital, Vejle, Denmark, ; Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Department of Clinical Research, University of Southern Denmark, Denmark,


Background: The most frequent indication for total hip arthroplasty (THA) revision surgery is aseptic loosening. Aseptic loosening is associated with increased wear of polyethylene liners, but wear may be reduced by using liners oxidatively stabilised with vitamin E.
Purpose / Aim of Study: Primary: To compare proximal femoral head penetration into the liner between a) vitamin E diffused highly cross-linked polyethylene (vE-PE) THA liners and conventional highly cross-linked polyethylene (XLPE) liners and b) 32 mm and 36 mm femoral heads. Secondary: To compare proximal cup migration between a) vE-PE and XLPE liners and b) 32 mm and 36 mm femoral heads. Exploratory: To compare patient-reported outcomes measures (PROMs) between 32 mm and 36 mm femoral heads.
Materials and Methods: Patients scheduled for a THA were randomised to receive vE-PE or XLPE liner with a CoCr femoral head size of 32 or 36 mm (4 intervention groups in a 2×2 factorial design). Head penetration and cup migration were measured using radiostereometric analysis (RSA) at baseline, 3, 12, 24, and 60 months postoperatively. PROMs (EQ-5D, SF-36, Harris Hip Score, and UCLA Activity Score) were assessed at baseline, 3, 12, 36, and 60 months. All outcome measures were analysed using linear mixed effects analysis.
Findings / Results: Of the 220 screened patients, 126 were included in this study, 117 received the allocated intervention, and 94 had their results analysed at five years. Head penetration was similar between liner materials and head sizes at five years, vE-PE versus XLPE was -0.084 mm (95% CI: [-0.173; 0.004], p = 0.06), and 32 mm versus 36 mm was -0.025 mm (95% CI: [-0.114; 0.065], p = 0.58), respectively. Cup migration was similar between liner and head sized at five years, vE-PE versus XLPE was 0.059 mm (95% CI: [-0.262; 0.380], p = 0.72), and 32 mm minus 36 mm was 0.042 mm (95% CI: [-0.283; 0.367], p = 0.80). No differences were found in any of the patient-reported outcome measures. None of the patients received revision surgery during the trial.
Conclusions: No difference in head penetration was found from baseline to five years between vE-PE and XLPE liners, or between 32 mm and 36 mm heads.

105. Hospital differences in mortality rates after hip fracture surgery in Denmark
Pia Kjær Kristensen, Juan Merlo, Nermin Ghith, George Leckie, Søren Paaske Johnsen
Department of Orthopaedic Surgery, Horsens Regional Hospital; Research Unit of Social Epidemiology, Lund University; Centre for Clinical Research and Prevention, Frederiksberg hospital; Centre for Multilevel Modelling, University of Bristol; Department of Clinical Medicine, Aalborg University


Background: Thirty-day mortality after hip fracture is widely used when ranking hospital performance, but the reliability of such hospital ranking is seldom calculated.
Purpose / Aim of Study: We aimed to quantify the variation in 30- day mortality across hospitals and to determine the hospital general contextual effect for understanding patient differences in 30-day mortality risk.
Materials and Methods: Patients aged ¡Ý65 years with an incident hip fracture registered in the Danish Multidisciplinary Fracture Registry between 2007 and 2016 were identified (n= 60,004). We estimated unadjusted and patient-mix adjusted risk of 30-day mortality in 32 hospitals. We performed multilevel analysis of individual heterogeneity and discriminatory accuracy with patients nested within hospitals. We expressed the hospital general contextual effect by the Median Odds Ratio, the area under the receiver operating characteristics curve and the variance partition coefficient.
Findings / Results: The overall 30-day mortality rate was 10%. Patient characteristics including high sociodemographic risk score, underweight, comorbidity, a subtrochanteric fracture and living at a nursing home were strong predictors of 30-day mortality (area under the curve= 0.728). The adjusted differences between hospital averages in 30-day mortality varied from 5% to 9% across the 32 hospitals, which correspond to a median odds ratio of 1.18 (95% CI: 1.12-1.25). However, the hospital general context effect was low, as the variance partition coefficient was below 1% and adding the hospital level to a single-level model with adjustment for patient-mix increased the area under the receiver operating characteristics curve by only 0.004 units.
Conclusions: Only minor hospital differences were found in 30-day mortality after hip fracture. Mortality after hip fracture needs to be lowered in Denmark but possible interventions should be patient oriented and universal rather than focused on specific hospitals.

106. Intermittent Systemic Hypoxic Therapy as Adjuvant Treatment in Rotator Cuff Reinsertion in Rats
Larsen Mikkel, Elmengaard Brian, Bergholt Natasja, Pedersen Michael, Foldager Casper
Orthopaedic Research Lab, Aarhus University Hospital; Center for Elective Surgery, Silkeborg Regional Hospital; Orthopaedic Research Lab, Aarhus University Hospital; Comparative Medicine Lab, Aarhus University; Orthopaedic Research Lab, Aarhus University Hospital


Background: Hypoxia affects the transcription of genes that control and regulate multiple cellular functions including initiation of angiogenesis and cell proliferation; a prerequisite tissue regeneration. Rotator Cuff injury is a common orthopaedic issue, often with an unfavourable outcome.
Purpose / Aim of Study: We hypothesize that treatment with systemic intermittent hypoxic therapy (SIHT) leads to an adaptive systemic response that will accelerate and improve bone-tendon regeneration. In an efficacy study we aim to evaluate the morphological outcome after use of SIHT as adjuvant treatment in surgical rotator cuff repair in rats.
Materials and Methods: Sixty-six 17-week old male Sprague Dawley rats were randomly divided into a two SIHT groups and a control group. The SIHT groups were exposed to systemic hypoxia (13.5% oxygen) for 1 hour in 12 hours intervals for 2 weeks in a closed oxygen- controlled chamber 14 days preoperative (SIHT14) or 7 days before and after surgery (SIHT7/7). The control group received ambient air. All rats received unilateral supraspinatus reinsertion after surgical release. The rats were euthanized after 2 and 4 weeks and evaluated with histology. Collagen fibre isotropy in the supraspinatus tendon was used as surrogate marker of tendon function and success of surgical repair The Student’s t-test was used to investigate difference between groups.
Findings / Results: A significant improvement in collagen fiber isotropy was observed in the SIHT7/7 (61.6%, SD=8.472) and the SIHT14 (62.7%, SD=8.947) groups 14 days postoperatively compared with controls (51.5%, SD=7.264) (p=0.0085 and p=0.0104, respectively). Twenty-eight days postoperative there were no significant differences between groups.
Conclusions: Systemic intermittent hypoxia therapy seems accelerate tendon-bone regeneration, but did not affect the long- term morphological outcome. SIHT has potential be a be an integrated perioperative treatment, but more investigations are needed.

107. Two-year results of trapeziometacarpal joint arthroplasty with the Moovis cup
Lene Dremstrup, Maiken Stilling, Kjærgaard Janni Thillemann, Lone Kirkeby, Lotte Priess Larsen, Torben Bæk Hansen
Universitetsklinik for hånd-, hofte- og knækirurgi, Hospitalsenheden Vest; Ortopædkirurgisk Afdeling, Aarhus Universitetshospital; Universitetsklinik for hånd-, hofte- og knækirurgi, Hospitalsenheden Vest; Universitetsklinik for hånd-, hofte- og knækirurgi, Hospitalsenheden Vest; Universitetsklinik for hånd-, hofte- og knækirurgi, Hospitalsenheden Vest; Universitetsklinik for hånd-, hofte- og knækirurgi, Hospitalsenheden Vest


Background: Early aseptic loosening of total trapeziometacarpal (TMC) joint arthroplasty is a major problem and may be related to implant design. A new generation dual mobility cementless conical cup design has shown promising short-term results.
Purpose / Aim of Study: To evaluate the 2-year results of the Moovis cup/Elektra stem for treatment of TMC osteoarthritis.
Materials and Methods: A consecutive cohort of the first 200 hands (97 right side) in 174 patients (37 men) operated with cementless Moovis cup/Electra stem at mean age 59 years (range 43-80) was followed for 2 years. There were 26 bilateral cases. We evaluated the preoperative Quick DASH (QDASH), grip strength and pain at rest and in activity measured on Numeric Rating Scale (NRS;0-10) for the first operated hand and report the 1 and 2-year improvement. Radiographs and complications were evaluated for all implants.
Findings / Results: Preoperative QDASH was mean 48 (median 48, IQR 33-61) and the improvement in QDASH score was mean 32 (SD 20) at both 1-year and 2 years(p<0.00). Preoperative grip strength was mean 21kg (median 20, IQR 13-27) in the operated hand. The improvement in grip strength was mean 6kg (SD 10) at 1 year and mean 8kg (SD 10) after 2 years(p<0.00). The preoperative pain score at rest (NRS) was mean 4 (SD 2.4), which improved to mean 0.8 (SD 1.7) at 1 year and mean 0.7 (SD 1.5) after 2 years (p<0.00). In activity, the preoperative pain score (NRS) was mean 8 (SD 1.7), which improved to 2.9 (SD 3.0) at 1-year and 2.6 (SD 3.1) at 2-years. Six hands (3%) with an intraoperative trapezium fracture were converted to a primary cemented cup(n=2) or trapeziectomy (primary or within 6 weeks) (n=4). Fourteen implants (7%) had secondary surgery without cup/stem revision, including three implants (1.5%) reoperated due to polyethylene wear. Except for one cup, all implants were well fixed based on visual judgement of radiographs at 2-years followup.
Conclusions: In this large cohort of TMC joint arthroplasty with Moovis cup and 2-year followup, the patients had clinically relevant and statistical significant improvement of subjective and objective outcomes. Early implant failure and implant revision were rare. The reoperation rate was relatively high, but primarily due to minor issues.

108. Degenerative changes on adjacent segments levels (ASD) with and without interbody fusion – 10 year MRI follow up on a RCT.
Kristian Høy, Lin Ding, Thomas Borbjerg Andersen, Niels Egund
Department of Orthopedics, Spine Section , Aarhus University Hospital, Denmark; Department of Orthopedics, The Rizhao Hospital of traditional Chinese medicine, Rizhao, China ; Spine Unit, Department of Orthopedics, University Hospital of Copenhagen, Rigshospitalet, Denmark; Department of Radiology, Aarhus University Hospital, Denmark


Background: Due to the high number of spinal procedures, performed worldwide adjacent degenerative disease (ASD) has become a new challenge. Whether ASD is a matter of normal degenerative development in the disc over time or a result of increased stiffness and stress, is still debated. TLIF is the most widely used interbody method. Interbody fusion is thought to reduce the degenerative changes in the free disc due to better sagittal balance and restoration of lumbar lordosis.
Purpose / Aim of Study: Comparison of degenerative MR findings in a RCT, 10 years after surgery.
Materials and Methods: 100 pat. included in a prospective RCT between interbody fusion (TLIF) and Instrumented posterolateral fusion (PLF) was offered a MRI at long-term follow up. MRIs were classified according to Modic, Pfirrmanns, Schizas, Fardon and Milette in order to estimate degeneration of the discs above and below fusion. Grading was done by two independent observers without any contact to the patient. In patients who underwent secondary surgery, the MR prior to that was used.
Findings / Results: 79 pat. were available for MR. The groups were equal regarding sex, age, diagnosis and number of operated levels. The follow up length was 9.6 years. The Modic change found at the first upper disc was none in (85% TLIF/68% PLF), if present mostly grade 2 Modic change (12%TLIF/26%PLF) was found. There were no significant difference between the two groups p=0.274. Most patients did not show any sign of treatment needs regarding spinal stenosis according to Schizas A&B, 92% (TLIF)/92% (PLF) only 8 % (TLIF)/8% (PLF) had type C and D at first upper level. No difference between groups could be detected p = 0.930. Pfirrmann grading at the first proximal level was type 1: 0%(TLIF)/0%(PLF), type 2: 17%(TLIF)/16% (PLF), type 3: 54%(TLIF)/43% (PLF), type 4: 27%(TLIF)/35%(PLF), type 5: 2%(TLIF)/5% (PLF). No difference between groups p = 0.952. Degenerative disc protrusion posterior according to Fardon and Milette was none: 61%(TLIF)/ 63%(PLF), and bulge: 39% (TLIF)/32%(PLF),protusion:0%(TLIF)/5% (PLF), extrusion 0%(TLIF)/0%(PLF), p= =0.289.
Conclusions: In a RCT, the use of interbody fusion (TLIF), do not reduce degenerative changes (ASD ) in MRI, in the upper or lower disc next to the fusion.

109. True frequency and risk factors for hip dislocation within two years after primary total hip arthroplasty (THA) – a Danish nationwide population-based study
Lars Lykke Hermansen, Bjarke Viberg, Lars Hansen, Søren Overgaard
Department of Orthopaedics, Hospital of South West Jutland, Esbjerg; Department of Orthopaedic Surgery and Traumatology, Kolding Hospital – a part of Lillebaelt Hospital, Kolding; Department of Orthopaedics, Hospital of South West Jutland, Esbjerg; The Orthopaedic Research Unit, Department of Orthopaedic Surgery and Traumatology and Department of Clinical Research , Odense University Hospital and University of Southern Denmark, Odense,


Background: Hip dislocation is one of the leading indications for revision hip surgery and the term ‘Revision due to dislocation’ is often how this complication is measured. The true occurrence of hip dislocation can be difficult to establish as closed reductions may not be captured in available registers.
Purpose / Aim of Study: The purpose of this study was to identify the true frequency of hip dislocation after primary THA and secondary to find risk factors for dislocation.
Materials and Methods: From the Danish Hip Arthroplasty Registry, we extracted 31.762 primary THAs inserted from 2010-2014 due to osteoarthritis with two years follow-up. Dislocations were identified through extraction from the Danish National Patient Registry. Matching diagnosis and procedure codes were deemed correct while non-matching codes were reviewed through a comprehensive, nationwide review of patient files. Risk factors were analyzed by logistic regression adjusting for age, sex, comorbidity (ASA- score), body mass index (BMI), head size, fixation and surgical approach. Results are presented as odds ratios (OR) with 95% confidence intervals.
Findings / Results: We identified 1890 dislocations in 1094 THAs which corresponds to a dislocation frequency of 3.4% (3.2-3.7) This is a 50% increase compared to the registry-captured frequency of 2.3% (2.1-2.5). Age<65 had lower risk (OR=0.71 (0.60-0.84) and age>75 higher risk of dislocation (OR=1.32 (1.14- 1.53) compared to age=65-74. ASA-score of 1 were associated with reduced risk (OR=0.69 (0.56-0.87)) and ASA-score of 3 with increased risk (OR=1.67 (1.35-2.06)) compared to ASA-2 Male gender (OR=0.85 (0.75-0.97)), cemented fixation (OR=0.70 (0.57-0.86)) and lateral approach (OR=0.30 (0.17-0.52)) were all associated with lower risk. Head size of 32mm (OR=1.26 (1.09- 1.45)) and 40mm (OR=1.56 (1.13-2.14)) had higher risk of dislocation than 36mm heads, while dual mobility cups had reduced risk (OR=0.13 (0.05-0.35)).
Conclusions: We report the true frequency of dislocations within two years after primary THA in Denmark between 2010-14 to be 3.4%, and while most literature report the risk factors for ‘Revision due do dislocation’, we are able to present several risk factors for all patients with hip dislocation and not only the revised.