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Bone & Joint Open
Vol. 5, Issue 1 | Pages 37 - 45
19 Jan 2024
Alm CE Karlsten A Madsen JE Nordsletten L Brattgjerd JE Pripp AH Frihagen F Röhrl SM

Aims

Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone.

Methods

Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the “after weightbearing” images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft.


Bone & Joint Open
Vol. 2, Issue 1 | Pages 40 - 47
1 Jan 2021
Kivle K Lindland ES Mjaaland KE Svenningsen S Nordsletten L

Aims

The gluteus minimus (GMin) and gluteus medius (GMed) have unique structural and functional segments that may be affected to varying degrees, by end-stage osteoarthritis (OA) and normal ageing. We used data from patients with end-stage OA and matched healthy controls to 1) quantify the atrophy of the GMin and GMed in the two groups and 2) describe the distinct patterns of the fatty infiltration in the different segments of the GMin and GMed in the two groups.

Methods

A total of 39 patients with end-stage OA and 12 age- and sex frequency-matched healthy controls were prospectively enrolled in the study. Fatty infiltration within the different segments of the GMin and the GMed was assessed on MRI according to the semiquantitative classification system of Goutallier and normalized cross-sectional areas were measured.


Aims

Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component.

Methods

In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component.


Bone & Joint Research
Vol. 8, Issue 10 | Pages 472 - 480
1 Oct 2019
Hjorthaug GA Søreide E Nordsletten L Madsen JE Reinholt FP Niratisairak S Dimmen S

Objectives

Experimental studies indicate that non-steroidal anti-inflammatory drugs (NSAIDs) may have negative effects on fracture healing. This study aimed to assess the effect of immediate and delayed short-term administration of clinically relevant parecoxib doses and timing on fracture healing using an established animal fracture model.

Methods

A standardized closed tibia shaft fracture was induced and stabilized by reamed intramedullary nailing in 66 Wistar rats. A ‘parecoxib immediate’ (Pi) group received parecoxib (3.2 mg/kg bodyweight twice per day) on days 0, 1, and 2. A ‘parecoxib delayed’ (Pd) group received the same dose of parecoxib on days 3, 4, and 5. A control group received saline only. Fracture healing was evaluated by biomechanical tests, histomorphometry, and dual-energy x-ray absorptiometry (DXA) at four weeks.


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1238 - 1247
1 Oct 2019
Soreide E Denbeigh JM Lewallen EA Thaler R Xu W Berglund L Yao JJ Martinez A Nordsletten L van Wijnen AJ Kakar S

Aims

Options for the treatment of intra-articular ligament injuries are limited, and insufficient ligament reconstruction can cause painful joint instability, loss of function, and progressive development of degenerative arthritis. This study aimed to assess the capability of a biologically enhanced matrix material for ligament reconstruction to withstand tensile forces within the joint and enhance ligament regeneration needed to regain joint function.

Materials and Methods

A total of 18 New Zealand rabbits underwent bilateral anterior cruciate ligament reconstruction by autograft, FiberTape, or FiberTape-augmented autograft. Primary outcomes were biomechanical assessment (n = 17), microCT (µCT) assessment (n = 12), histological evaluation (n = 12), and quantitative polymerase chain reaction (qPCR) analysis (n = 6).


The Bone & Joint Journal
Vol. 101-B, Issue 7 | Pages 793 - 799
1 Jul 2019
Ugland TO Haugeberg G Svenningsen S Ugland SH Berg ØH Pripp AH Nordsletten L

Aims

The aim of this randomized trial was to compare the functional outcome of two different surgical approaches to the hip in patients with a femoral neck fracture treated with a hemiarthroplasty.

Patients and Methods

A total of 150 patients who were treated between February 2014 and July 2017 were included. Patients were allocated to undergo hemiarthroplasty using either an anterolateral or a direct lateral approach, and were followed for 12 months. The mean age of the patients was 81 years (69 to 90), and 109 were women (73%). Functional outcome measures, assessed by a physiotherapist blinded to allocation, and patient-reported outcome measures (PROMs) were collected postoperatively at three and 12 months.


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1138 - 1145
1 Sep 2018
Soreide E Murad MH Denbeigh JM Lewallen EA Dudakovic A Nordsletten L van Wijnen AJ Kakar S

Aims

Dupuytren’s contracture is a benign, myoproliferative condition affecting the palmar fascia that results in progressive contractures of the fingers. Despite increased knowledge of the cellular and connective tissue changes involved, neither a cure nor an optimum form of treatment exists. The aim of this systematic review was to summarize the best available evidence on the management of this condition.

Materials and Methods

A comprehensive database search for randomized controlled trials (RCTs) was performed until August 2017. We studied RCTs comparing open fasciectomy with percutaneous needle aponeurotomy (PNA), collagenase clostridium histolyticum (CCH) with placebo, and CCH with PNA, in addition to adjuvant treatments aiming to improve the outcome of open fasciectomy. A total of 20 studies, involving 1584 patients, were included.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_1 | Pages 47 - 47
1 Jan 2018
Nordsletten L Tsukanaka M Halvorsen V Engesaeter I Engesaeter L Fenstad A Rohrl S
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Total hip replacement (THR) in children and very young teenagers is experimental since we do not know long-term results in these. We investigated the clinical and radiographic outcomes of THR performed in children and teenage patients identified in the Norwegian Arthroplasty Register

We included 111 patients (132 hips) who underwent THR before 20 years of age., together with information on the primary diagnosis, types of implants, and any revisions that required implant change. Radiographs and Harris hip score (HHS) were evaluated for patients that attended clinical follow-up.

The mean age at primary THR was 17 (11–19) years, 60% were girls. Mean follow-up time was 14 (3–26) years. The 10-year survival rate after primary THR (with endpoint any revision) was 70%. Survival was better for the patients operated after 1996 (10 y 50% vs 90%). 39 patients had at least 1 revision and 16 patients had 2 or more revisions. In the latest radiographs, osteolysis and atrophy were observed in 19% and 27% of the acetabulae and 21% and 62% of the femurs, respectively. The mean HHS at the final follow-up was 83 (15–100). EQ-5DVAS was 74 (82 in normal population).

The clinical scores after THR in these young patients were acceptable, but many revisions had been performed. The bone stock in many patients was poor, which could complicate future revisions.


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 755 - 761
1 Jun 2015
Flatøy B Röhrl SM Rydinge J Dahl J Diep LM Nordsletten L

Cemented femoral stems with force closed fixation designs have shown good clinical results despite high early subsidence. A new triple-tapered stem in this category (C-stem AMT) was introduced in 2005. This study compares this new stem with an established stem of similar design (Exeter) in terms of migration (as measured using radiostereometric analysis), peri-prosthetic bone remodelling (measured using dual energy x-ray densitometry, DXA), Oxford Hip Score, and plain radiographs.

A total of 70 patients (70 hips) with a mean age of 66 years (53 to 78) were followed for two years. Owing to missing data of miscellaneous reasons, the final analysis represents data from 51 (RSA) and 65 (DXA) patients. Both stems showed a typical pattern of migration: Subsidence and retroversion that primarily occurred during the first three months. C-stem AMT subsided less during the first three months (p = 0.01), before stabilising at a subsidence rate similar to the Exeter stem from years one to two. The rate of migration into retroversion was slightly higher for C-stem AMT during the second year (p = 0.03). Whilst there were slight differences in movement patterns between the stems, the C-stem AMT exhibits good early clinical outcomes and displays a pattern of migration and bone remodelling that predicts good clinical performance.

Cite this article: Bone Joint J 2015;97-B:755–61.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 228 - 228
1 Sep 2012
Stoen R Nordsletten L Madsen J Lofthus C Frihagen F
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Introduction

Many patients with displaced intracapsular femoral neck fractures (IFNF) are treated with hemiarthroplasty (HA) which has been shown superior to internal fixation(IF) the first year after injury. Long term results, however, are sparse.

Methods

A total of 222 consecutive patients above 60 years, including mentally disabled, with IFNF were randomized to either internal fixation with two parallel screws or hemiarthroplasty, and operated by the surgeon on call. After 5 years, 68 of the 70 surviving patients accepted a follow-up visit. The reviewers were blinded for initial treatment.


Bone & Joint Research
Vol. 1, Issue 6 | Pages 125 - 130
1 Jun 2012
Bøe BG Støen RØ Solberg LB Reinholt FP Ellingsen JE Nordsletten L

Objectives

An experimental rabbit model was used to test the null hypothesis, that there is no difference in new bone formation around uncoated titanium discs compared with coated titanium discs when implanted into the muscles of rabbits.

Methods

A total of three titanium discs with different surface and coating (1, porous coating; 2, porous coating + Bonemaster (Biomet); and 3, porous coating + plasma-sprayed hydroxyapatite) were implanted in 12 female rabbits. Six animals were killed after six weeks and the remaining six were killed after 12 weeks. The implants with surrounding tissues were embedded in methyl methacrylate and grinded sections were stained with Masson-Goldners trichrome and examined by light microscopy of coded sections.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 142 - 143
1 May 2011
Frihagen F Waaler G Madsen JE Nordsletten L Aspaas S Aas E
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The costs of hip fractures are high. For the individual suffering a hip fracture there are both physical and psychological costs. For society there are costs of medical attention such as hospital treatment, rehabilitation and an increased level of care. We aimed to assess whether total hospital and societal costs for the treatment of elderly patients with displaced femoral neck fractures differ between patients operated with either internal fixation or hemiarthroplasty.

Patients: 222 patients, 165 (74%) women, mean age 83 years, were randomized to either internal fixation or hemiarthroplasty and followed for 2 years. All patients, regardless of cognitive failure and poor function and health were included in the study. Patients underwent either a Charnley-Hastings bipolar cemented hemiarthro-plasty or closed reduction and internal fixation with two parallel cannulated screws (Olmed). Resource use in hospital, rehabilitation, community based care and nursing home use were prospectively included in the analysis.

Results: The average cost per patient for the initial hospital stay was significantly lower for patients in the internal fixation group compared to the hemiarthro-plasty group (€ 12,509 vs. € 16,923, p= 0.01). When all femoral neck fracture-related hospital costs, i.e. rehabilitation, re-operations and formal and informal contact with the hospital, were included, the cost was similar in two groups (€ 25,081 for internal fixation vs. € 26,828 for hemiarthroplasty, p= 0.52). Including all costs (all hospital admissions, cost of nursing home and community based care), there was a nonsignificant trend that internal fixation was the most expensive treatment, (€ 50,331 vs. € 42,615 (p=0.14)). Inpatient stay and nursing home use were the two must resource demanding items for both groups. Costs for re-operations was the area where the largest difference between the groups was found (€ 9,377 per patient for internal fixation vs. € 1,718 for hemiarthroplasty (p< 0.01).

Conclusion: The initial lower cost per patient for internal fixation as treatment of a femoral neck fracture cannot be used as an argument in favor of this treatment, since the difference in average cost per patient is more than outweighed by subsequent costs, mainly due to a higher re-operation rate after internal fixation than after hemiarthroplasty and a tendency to higher societal costs. The old orthopedic credo that internal fixation is the cheaper treatment, and thus should be preferred, could not be verified when other costs than the initial hospital stays were included.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 141 - 141
1 May 2011
Frihagen F Waaler G Madsen JE Nordsletten L Aspaas S Aas E Frihagen F
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Background: Alternative treatments in displaced fractures of the femoral neck include reduction and internal fixation, and arthroplasty. A variety of treatments are continuously introduced to the health care market and that makes prioritising, based on the severity of the disease, the effectiveness, and the cost effectiveness of the treatment, necessary. The aim of this study was to compare the estimated effect and costs of internal fixation and hemiarthroplasty after a displaced femoral neck fracture.

Methods: 222 patients, 165 (74%) women, mean age 83 years, were randomized to internal fixation (n = 112) and hemiarthroplasty (n = 110). Mainly due to cognitive failure or death, 56 patients failed to complete the EQ-5D questionnaire at any follow up; hence, 166 patients were included in the analysis. There were no differences in the demographic variables at inclusion. Patients underwent either a Charnley-Hastings bipolar cemented hemiarthroplasty or closed reduction and internal fixation with two parallel cannulated screws (Olmed). The health effect was estimated by the generic measure quality adjusted life-years (QALYs). The QALYs were estimated based on the patients’ perception of quality of life (QoL) assessed by Eq-5d, which was measured after 4, 12 and 24 months.

Results: Over the two year period the expected QALYs for patient with hemiarthroplasty and internal fixation were estimated to be 1.31 and 1.11, respectively. Thus, the incremental health effect, the difference in QALYs for hemiarthroplasty versus internal fixation, was 0.20 QALYs gained. Hospital costs over two years were € 30 726 in the internal fixation group and € 27 618 in the hemiarthroplasty group, an incremental cost of – € 3 108 in favor of hemiarthroplasty. Total costs, including societal costs, were € 62 815 in the internal fixation group, compared to € 48 227 in the hemiarthroplasty group, an incremental cost of – € 14 588 in favor of hemiarthroplasty. By dividing the incremental cost by the incremental effect, we found the incremental cost effectiveness ratio (ICER) to be – € 15 540 for all hospital costs and – € 72 940 for total costs. Sensitivity analysis based on the bootstrap method, indicate that the ICER is significantly negative, indicating both a significantly lower incremental costs and significantly higher QALYs for hemiarthroplasty versus internal fixation. Conclusion: Primary treatment with hemiarthroplasty generates more QALYs and is less costly compared to internal fixation. Hemiarthroplasty was thus the cost effective treatment alternative.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 9 | Pages 1303 - 1305
1 Sep 2010
Benum P Aamodt A Nordsletten L

Traditional techniques for the insertion of femoral stems in arthroplasty of the hip in osteopetrosis carry a considerable risk of penetration of the femoral cortex and intra-operative fractures, due to obliteration of the intramedullary cavity and greatly increased stiffness and brittleness of the bone. In order to reduce the risk of such complications we manufactured a customised stem and a computer-based guiding device for the preparation of a cavity within the proximal femur. This system was used successfully in three hips in two patients. We describe the system and the operative technique.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 387 - 387
1 Jul 2010
Dahl J Rydinge J Rohrl S Snorrason F Nordsletten L
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Introduction: C-stem is a triple taper polished femoral stem. The rationale for this design is to achieve an evenly distributed proximal loading of the cement mantle. This design is thought to enhance stability of the stem inside the mantle and lead to bone remodelling medially. There is to our knowledge no randomized trial comparing this stem to a well documented stem. We chose to compare it to the best documented stem in the Norwegian arthroplasty register, the Charnley monoblock.

Methods: 70 patients scheduled for total hip replacement were randomized to either C-stem or Charnley monoblock. All received a 22 mm stainless steel head, OGGEE cup and Palacos Cement with Gentamycin. We used a transgluteal approach in all cases. Harris and Oxford hip scores were measured preoperatively and after two years. Standard X-rays were taken postoperatively and after two years. Radiostereometry (RSA) was done postoperatively and after 3,6,12 and 24 months.

Results: There was no significant difference in Harris or Oxford hip scores after two years.

RSA after two years: (table deleted)

Discussion: Polished tapered stems are designed to sink inside the mantle. Our results confirm this theory for the C-stem. The subsidence is comparable to other collarless tapered stems with good long-term survival. For all other migrations/rotations the C-stem is as stable as the Charnley monoblock. This predicts good long-term results for this stem.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 392 - 392
1 Jul 2010
Dahl J Nivbrant B Søderlund P Nordsletten L Röhrl SM
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Introduction: Increased wear is associated with aseptic loosening and late dislocations. Hard on hard bearings may reduce wear but still have topics of concern such as free metal ions in metal on metal bearings and the risk for fracture in ceramic articulations. Ceramic heads against conventional polyethylene is also used with the intention to reduce wear. But this effect has not been conclusively documented in the literature and is still discussed. 87 patients were operated consecutively by the same surgeon with the same surgical technique. All patients received a cemented all poly cup sterilized with irradiation in inert atmosphere and a cemented stem. Head size was 28 mm in all patients. 40 patients received cobalt-chrome heads and 47 patients aluminiumoxid heads. The patients were followed with RSA for 10 years and analysed for wear.

Results: Mean (SEM) wear for the group with cobalt chrome heads was 0.93 mm (0.13) and for the group with aluminiumoxide was 0.43 mm (0.08) (p = 0.001).

Discussion: We found significantly less wear with aluminumoxide heads compared to cobalt-chrome heads. The wear results in the cobalt-chrome group correlate well to wear values in the literature for conventional polyethylene. Although the polyethylene in this study is partly cross-linked (3Mrad) it is not clear whether these results can be extrapolated directly to the use of highly cross-linked PE. If longer follow-ups confirm the mechanical stability of highly cross-linked PE, ceramic heads might contribute additionally to the reduction of wear.

In conclusion we found significantly reduced wear for aluminumoxide heads compared to cobalt chrome heads which could be beneficial for young and active patients.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 332 - 332
1 May 2010
Nordsletten L Lyles K Colon-Emeric C Magaziner J Adachi J Pieper C Hyldstrup L Eriksen EF Boonen S
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Fracture prevention has so far been studied in patients included on the basis of low bone density, and not after a fracture. In this study the inclusion criteria was a new hip fracture irrespective of bone density. An international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial (HORIZON-RFT) studied whether the bisphosphonate, zoledronic acid (ZOL) 5 mg, reduced subsequent clinical fractures in men and women ≥50 yrs after a hip fracture.

Methods: Patients with hip fracture were included. They received daily vitamin D3 and calcium supplements. Of 2127 randomized, 2111 were treated with once-yearly IV infusions of ZOL 5 mg (n=1054) or placebo (PBO; n=1057) and followed until 211 experienced new clinical fractures (the primary efficacy endpoint).

Results: Baseline characteristics were similar. Median age was 76 yrs (range, 50–98); 76% were women. Clinical fractures occurred in 92 ZOL and 139 PBO patients. 2-year cumulative event rates were 8.59% and 13.88%, respectively (Kaplan-Meier); relative risk reduction was 35% (HR=0.65; 95% CI: 0.50–0.84; P=.0012). ZOL reduced risk for clinical vertebral and nonvertebral fractures vs. PBO by 46% (HR=0.54; 95% CI: 0.32–0.92; P=.0210) and 27% (HR=0.73; 95% CI: 0.55–0.98; P=.0338), respectively. ZOL reduced risk of hip fractures by 30% vs. PBO (HR=0.70; 95% CI: 0.41–1.19; P=NS). AEs and SAEs were comparable between groups. There were no significant differences in cardiovascular parameters or long-term renal function. No cases of ONJ were reported. Death occurred in 9.58% of ZOL patients vs 13.34% PBO, a 28% lower mortality risk (HR=0.72; 95% CI: 0.56–0.93, P=.0117).

Conclusions: Subjects with a new hip fracture treated with annual IV ZOL infusions experienced significantly fewer clinical fractures vs. placebo. ZOL was well tolerated with a favorable safety profile. This is the first trial demonstrating a mortality benefit for an antiresorptive agent.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 89 - 89
1 Mar 2009
Isaac G Fleming J Kay P Nordsletten L Stone M
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Hip arthroplasty has its true genesis in 1962 when the Charnley Total Hip was first implanted. The system comprised a stainless steel femoral stem with fixed 22,225mm head articulating against an all polyethylene acetabular cup. Both components were fixed in position with acrylic bone cement. There have been a number of changes in design, materials and surgical technique but the essential concept remains the same. The system was widely used by both senior and junior surgeons. Numerically implantations peaked at ~45,000 per annum in the late1980’s and is still at around ~25,000 per annum in the mid 2000’s. Geographically the system was used in all five continents. Patients varied widely both in age, activity, and diagnosis. It would therefore seem an appropriate vehicle to examine the variations in results of total hip replacement by patient profile, geography, and era of implantation.

A search was carried out on the US NCBI website for publications reporting on results with the Charnley system up to the end of 2002, and which comprised a follow-up of more than 10 years, and gave survivorship data. This resulted in 28 papers with 14 countries of origin available for review. For all studies basic data such as age and diagnosis, range implantation dates, likely specific design of prosthesis, origin of study and number in study was either reported or could be deduced. A ten year survivorship was reported in 16 studies for stem and cup and 7 for stem only. If the longest follow-up was considered for each study then 18 reported on stem and cup (9392 hips, implanted 1962–92) and 15 on stem only (4243 hips, implanted 1966–91). A total of 11 studies had four of more points on a survivorship curve, seven with stem and cup, four with stem only.

There are a number of points of interest in this data. The first is that with one exception the performance is remarkably consistent as shown by the survivorship curves. There is no significant difference in the survival rates from different centres, countries, and with implantation dates ranging from 1962 through to 1992. Secondly, there appears to have been little or no change in the average age of patients with implant date. There is some evidence to indicate from the 10 year data that failure rate per year is lower in older patients but does not seem to be affected by implantation date. The latter despite the fact that both surgical technique and component design changed over the 30 year implantation period. A further observation is that the failure rate per year is lower in studies with greater numbers of patients.

The general conclusion from this review is that the Charnley Total Hip is remarkably consistent in its performance both over time and location of implantation. Its performance also seems to have been affected very little by changes in technique or design.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 259 - 263
1 Feb 2009
Dimmen S Nordsletten L Engebretsen L Steen H Madsen JE

Conventional non-steroidal anti-inflammatory drugs (NSAIDs) and newer specific cyclo-oxygenase-2 (cox-2) inhibitors are commonly used in musculoskeletal trauma and orthopaedic surgery to reduce the inflammatory response and pain. These drugs have been reported to impair bone metabolism. In reconstruction of the anterior cruciate ligament the hamstring tendons are mainly used as the graft of choice, and a prerequisite for good results is healing of the tendons in the bone tunnel. Many of these patients are routinely given NSAIDs or cox-2 inhibitors, although no studies have elucidated the effects of these drugs on tendon healing in the bone tunnel.

In our study 60 female Wistar rats were randomly allocated into three groups of 20. One received parecoxib, one indometacin and one acted as a control. In all the rats the tendo-Achillis was released proximally from the calf muscles. It was then pulled through a drill hole in the distal tibia and sutured anteriorly. The rats were given parecoxib, indometacin or saline intraperitoneally twice daily for seven days. After 14 days the tendon/bone-tunnel interface was subjected to mechanical testing.

Significantly lower maximum pull-out strength (p < 0.001), energy absorption (p < 0.001) and stiffness (p = 0.035) were found in rats given parecoxib and indometacin compared with the control group, most pronounced with parecoxib.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 183 - 184
1 Mar 2006
Nordsletten L Valentin-Opran A
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Open tibia fractures are often associated with delayed union and non-union. The use of recombinant human bone morphogenetic protein-2 (rhBMP-2) to treat acute, open tibial shaft fractures has been approved in both Europe (InductOs) and the United States (INFUSE Bone Graft). These approvals were based on the results of a prospective, randomized study of 450 patients with open tibia fractures that has already been published (Govender et al. 2002).

Material and Methods: A sub-group of patients from the above study with Gustilo Grade IIIA and IIIB open tibia fractures was separately analyzed. Patients treated with the standard of care (intramedullary nail fixation and routine soft-tissue management [the control group]) were compared to those that received the standard of care and an implant containing the approved concentration of rhBMP-2 (1.50 mg/mL). The primary outcome measured was the incidence of secondary intervention to promote bone healing during the twelve months of follow-up. Fischer’s exact test was used to compare the two groups.

Results: There were 55 patients in the control group and 59 patients in the rhBMP-2 group. The combined incidence of nail dynamization (those both performed and from broken screws) was higher in the control group 28/55 than the rhBMP-2 group 18/59. Significantly more control patients required autologous bone grafting because of delayed union or non-union as compared to the rhBMP-2 group [10/55 (18%) versus 1/59 (2%), respectively; p=0.0033]. More patients in the control group 15/55 required invasive secondary interventions to promote bone healing than those in the rhBMP-2 group 6/59 (p=0.0283). Fewer infections were observed in the rhBMP-2 group 14/59 as compared to the control group 23/55. In addition, the average time to full weight bearing for patients was 34 days sooner when rhBMP-2 was used (96 versus 130 days).

Conclusions: The addition of rhBMP-2 to the treatment of open tibia fractures represents a significant improvement over the standard of care. Treatment of Grade III tibia fractures with rhBMP-2 was shown to reduce the incidence of both invasive secondary interventions and infections. The additional expense of using rhBMP-2 can be justified for these severe fractures, by the potential to eliminate of the cost required to treat these complications.