Aims. The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years. Patients and Methods. Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year. Results. A total of 19 patients were randomised to non-operative (n = 8) or operative (n = 11; tension-band wiring (n = 9), plate (n = 2)) management. The trial was stopped prematurely as the rate of complications (nine out of 11, 81.8%) in the operative group was considered to be unacceptable. There was, however, no difference in the mean DASH scores between the groups at all times. The mean score was 23 (0 to 59.6) in the non-operative group and 22 (2.5 to 57.8) in the operative group, one year after the injury (p = 0.763). There was no significant difference between groups in the secondary outcome measures of the Broberg and Morrey Score or the Mayo Elbow Score at any time during the one year following injury (all p ≥ 0.05). . Conclusion. These data further support the role of primary non-operative management of isolated displaced fractures of the olecranon in the elderly. However, the non-inferiority of non-operative management cannot be proved as the trial was stopped prematurely. Cite this article: Bone Joint J 2017;99-B:964–72

It remains a matter of debate whether displaced fractures of the neck of the femur should be treated by internal fixation or arthroplasty. We have compared the two methods with regard to complications, mortality and functional outcome.

We studied 409 patients, aged 70 years and over, with subcapital fractures graded as Garden 3 or 4, in a two-year prospective multicentre study from 12 Swedish hospitals. They were randomised to internal fixation or arthroplasty. Patients who were mentally confused, bedridden or in a nursing-home were excluded from the survey.

After two years the rate of failure was 43% in the internal fixation (IF) and 6% in the arthroplasty group (p < 0.001). In the IF group 36% had impaired walking and 6% had severe pain compared with 25% and 1.5%, respectively, in the arthroplasty group (both p < 0.05). There was no difference in mortality.

With a high rate of failure and poor functional outcome after IF, we recommend primary arthroplasty for displaced fractures of the neck of the femur in patients over 70 years of age.

Our aim was to compare polylevolactic acid screws with titanium screws when used for fixation of the distal tibiofibular syndesmosis at mid-term follow-up. A total of 168 patients, with a mean age of 38.5 years (18 to 72) who were randomly allocated to receive either polylevolactic acid (n = 86) or metallic (n = 82) screws were included. The Baird scoring system was used to assess the overall satisfaction and functional recovery post-operatively. The demographic details and characteristics of the injury were similar in the two groups. The mean follow-up was 55.8 months (48 to 66). The Baird scores were similar in the two groups at the final follow-up. Patients in the polylevolactic acid group had a greater mean dorsiflexion (p = 0.011) and plantar-flexion of the injured ankles (p < 0.001). In the same group, 18 patients had a mild and eight patients had a moderate foreign body reaction. In the metallic groups eight had mild and none had a moderate foreign body reaction (p <  0.001). In total, three patients in the polylevolactic acid group and none in the metallic group had heterotopic ossification (p = 0.246).

We conclude that both screws provide adequate fixation and functional recovery, but polylevolactic acid screws are associated with a higher incidence of foreign body reactions.

Cite this article: Bone Joint J 2014;96-B:548–54.

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study.

A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware.

We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed.

We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures.

This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr

This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture. A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period. The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction. Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures

We have compared the results of simple patellectomy (group A, n = 16) and patellectomy with advancement of the vastus medialis obliquus (group B, n = 12) in a prospective, randomised trial, with a minimum follow-up of three years. The results in group B were significantly better (p < 0.001) than those in group A. Although the patella should be preserved if possible, we advocate advancement of the vastus medialis obliquus when patellectomy is necessary

Aims. This is a prospective randomised controlled trial comparing the functional outcomes of plate fixation and elastic stable intramedullary nailing (ESIN) of completely displaced mid-shaft fractures of the clavicle in the active adult population. Patients and Methods. We prospectively recruited 123 patients and randomised them to either plate fixation or ESIN. Patients completed the Quick Disabilities of the Arm, Shoulder and Hand (DASH) score at one to six weeks post-operatively. They were followed up at six weeks, three and six months and one year with radiographs, and their clinical outcome was assessed using both the DASH and the Constant Score. Results. Plate fixation provided a faster functional recovery during the first six months compared with ESIN, but there was no difference after one year. The duration of surgery was shorter for ESIN (mean 53.4 minutes, 22 to 120) than for plate fixation (mean 69.7 minutes, 35 to 106, p < 0.001). The recovery after ESIN was slower with increasing fracture comminution and with open reduction (p < 0.05). Conclusion. Both methods return the patients to their pre-injury functional levels, but plate fixation has a faster recovery period in comminuted fractures than ESIN. ESIN has a shorter operative time and lower infection and implant rates of failure when using 2.5 mm nails or wider, suggesting that this is the preferred method in mid-shaft fractures with no comminution, whereas plate fixation is the superior method in comminuted fractures. Cite this article: Bone Joint J 2017;99-B:1095–1101

We performed a prospective, randomised trial on 120 patients with redisplaced fractures of the distal radius comparing four methods of treatment. The four treatment groups, each containing 30 patients, were remanipulation and plaster, open reduction and bone grafting, and closed external fixation with and without mobilisation of the wrist at three weeks. The radiological results showed improvement in angulation of the distal radius for the open reduction and bone grafting group. Functional results at six weeks, three and six months and at one year, however, showed no difference between any of the four groups. The main influence on final outcome was carpal malalignment which had a statistically significant negative effect on function

The aims of this study were to undertake a prospective randomised trial to compare functional outcome, and range of motion after treatment of medial collateral ligament injuries by either early unprotected mobilisation or mobilisation with a hinged brace. Patients were randomised into either unprotected mobilisation or mobilisation with a hinged brace. Assessments occurred at 2 weeks, 6 weeks, 3 months and 6 months. Outcome measures included validated questionnaires (International Knee Documentation Committee and Knee Injury and Osteoarthritis Outcome Score scores), range of motion measurements and strength testing. Eighty six patients (mean age 30.4) were recruited. There were 53 men and 33 women. The mode of injury was sport in 56 patients (65%) with football, rugby and skiing being the most common types of sport involved. The mean time to return to full weight bearing was 3 weeks in both groups. The mean time to return to work was 4.6 weeks in the braced group and 4.1 weeks in the non-braced group (p=0.79). Return to running was at a mean of 14.3 weeks in the braced group and 12.8 weeks in the non-braced group (p=0.64). Return to full sport was 22 weeks in the braced group and 22.1 weeks in the non-braced group (p=0.99). There was no significant difference in range of movement or pain scores between the two groups at 2,6,12 and 24 weeks. The use of a hinged knee brace does not influence recovery after a medial collateral injury

We performed a prospective, randomised trial in 39 patients with open tibial fractures treated initially by external fixation to compare cast immobilisation (group A) and intramedullary nailing (group B) as a sequential protocol planned from the onset of treatment. The results showed that group B achieved faster union (p < 0.05) than group A with less malunion or shortening and a greater range of movement. Patients treated by intramedullary nailing required fewer radiographs and outpatient visits (p = 0.0015) and had a more predictable and rapid return to full function. We feel that these severe fractures are better treated by delayed intramedullary nailing and that this has an acceptable rate of complications

Our study was designed to compare the effect of indometacin with that of a placebo in reducing the incidence of heterotopic ossification in a prospective, randomised trial. A total of 121 patients with displaced fractures of the acetabulum treated by operation through a Kocher-Langenbeck approach was randomised to receive either indometacin (75 mg) sustained release, or a placebo once daily for six weeks. The extent of heterotopic ossification was evaluated on plain radiographs three months after operation. Significant ossification of Brooker grade III to IV occurred in nine of 59 patients (15.2%) in the indometacin group and 12 of 62 (19.4%) receiving the placebo. We were unable to demonstrate a statistically significant reduction in the incidence of severe heterotopic ossification with the use of indometacin when compared with a placebo (p = 0.722). Based on these results we cannot recommend the routine use of indometacin for prophylaxis against heterotopic ossification after isolated fractures of the acetabulum

We performed a prospective, randomised trial to evaluate the outcome after surgery of displaced, unstable fractures of the distal radius. A total of 280 consecutive patients were enrolled in a prospective database and 88 identified who met the inclusion criteria for surgery. They were randomised to receive either bridging external fixation with supplementary Kirschner-wire fixation or volar-locked plating with screws. Both groups were similar in terms of age, gender, hand dominance, fracture pattern, socio-economic status and medical co-morbidities. Although the patients treated by volar plating had a statistically significant early improvement in the range of movement of the wrist, this advantage diminished with time and in absolute terms the difference in range of movement was clinically unimportant. Radiologically, there were no clinically significant differences in the reductions, although more patients with AO/OTA (Orthopaedic Trauma Association) type C fractures were allocated to the external fixation group. The function at one year was similar in the two groups. No clear advantage could be demonstrated with either treatment but fewer re-operations were required in the external fixation group

In a prospective, randomised trial of 81 patients with fractures of the ankle of AO types A, B and C we compared two regimes of postoperative management after internal fixation. The patients were mobilised either non-weight-bearing with crutches or weight-bearing in a below-knee walking plaster. We found a temporary benefit in subjective evaluation only (65 v 50 points, Mann-Whitney test, cft, p = 0.02) for those with a below-knee walking plaster. There were no significant differences between the groups in the loaded dorsal range of movement (25° v 23°, Mann-Whitney test, cft, p = 0.16) or in the overall clinical result. Both treatments were considered to be satisfactory and their choice depends on the ability to mobilise non-weight-bearing, wound healing, the type of work and personal preference

The objective of this study was to compare differences in alignment following robotic arm-assisted bi-unicompartmental knee arthroplasty (Bi-UKA) and conventional total knee arthroplasty (TKA). This was a prospective, randomised controlled trial of 70 patients. 39 TKAs were implanted manually, as per standard protocol at our institution, and 31 Bi-UKA patients simultaneously received fixed-bearing medial and lateral UKAs, implanted using robotic arm-assistance. Preoperative and 3-month postoperative CT scans were analysed to determine hip knee ankle angle (HKAA), medial distal femoral angle (MDFA), and medial proximal tibial angle (MPTA). Analysis was repeated for 10 patients by a second rater to validate measurement reliability by calculating the intra-class correlation coefficient (ICC). Mean change in HKAA towards neutral was 2.7° in TKA patients and 2.3° in Bi-UKA patients (P=0.6). Mean change in MDFA was 2.5° for TKA and 1.0° for Bi-UKA (P<0.01). Mean change in MPTA was 3.7° for TKA and 0.8° for Bi-UKA (P<0.01). Mean postoperative MDFA and MPTA for TKAs were 89.8° and 89.6° respectively, indicating orientation of femoral and tibial components perpendicular to the mechanical axis. Mean postoperative MDFA and MPTA for Bi-UKAs were 91.0° and 86.9° respectively, indicating a more oblique joint line orientation. Inter-rater agreement was excellent (ICC>0.99). Early functional activities, according to the new Knee Society Scoring System, favoured Bi-UKAs (P<0.05). Robotic arm-assisted, cruciate-sparing Bi-UKA better maintains the natural anatomy of the knee in the coronal plane and may therefore preserve normal joint kinematics, compared to a mechanically aligned TKA. This has been achieved without significantly altering overall HKAA

We performed a prospective, randomised trial comparing three treatments for displaced intracapsular fractures of the hip in 280 patients aged 65 to 79 years. The mean patient survival was significantly higher in the group undergoing reduction and internal fixation (79 months) compared with that with a cemented Thompson hemiarthroplasty or a cemented Monk bipolar hemiarthroplasty (61 months and 68 months, respectively). After three years, 32 of 93 patients (34.4%) who had undergone fixation had local complications, necessitating further intervention in 28 (30%). There were no significant differences in the functional outcome in survivors, who were reviewed annually to five years. Either reduction and internal fixation or cemented hemiarthroplasty may be offered as alternative treatments for a displaced intracapsular fracture in a mobile and mentally competent patient under the age of 80 years. The choice of procedure by the patient and the surgeon should be determined by the realisation that the use of internal fixation is associated with a 30% risk of failure requiring further surgery. If this is accepted, however, hemiarthroplasty is avoided, which, in our study has a significantly shorter mean survival time. The use of a bipolar prosthesis has no significant advantage

In a prospective, randomised trial, we compared the use of three Ullevaal hip screws with that of two Hansson hook-pins in 278 patients with fractures of the femoral neck. Background factors were similar in both groups. Follow-up was for two years. There were no significant differences between the groups in length of time of surgery, hospital stay, general complications, mortality, pain or walking ability. Likewise, the rates of early failure of fixation, nonunion, and the need for reoperation did not differ significantly between the groups. The use of hook-pins was associated with less drill penetrations of the femoral head during surgery (odds ratio 2.6, p= 0.05) and a lower incidence of necrosis of the femoral head (odds ratio 3.5, p = 0.04). There was a strong relationship between poor reduction and fixation of the fracture and subsequent reoperation (p = 0.0005 and p = 0.0001, respectively). Likewise, peroperative drill penetration of the femoral head was associated with a greater risk of reoperation (p = 0.038). Both methods gave favourable results. In total, 22% of the patients needed a major reoperation (usually hemiarthroplasty), while in 7% of the cases the fixation device needed to be removed. Osteosynthesis as the sole method for operation of all fractures of the femoral neck was thus successful in 78% of patients. With selective treatment most of the remaining patients would have benefited if treated by a primary arthroplasty. Accurate selection requires the development of better prognostic methods

We have carried out a prospective, randomised trial to measure the rise of temperature during reaming of the tibia before intramedullary nailing. We studied 34 patients with a mean age of 35.1 years (18 to 63) and mean injury severity score of 10 (9 to 13). The patients were randomised into two groups: group 1 included 18 patients whose procedure was undertaken without a tourniquet and group 2, 16 patients in whom a tourniquet was used. The temperature in the bone was measured directly by two thermocouples inserted into the cortical bone near the isthmus of the tibial diaphysis. Reaming was carried out to at least 1.5 mm above the required diameter of the nail. Blood loss was assessed by recording the preoperative and postoperative haemoglobin (Hb) level. The minimum clinical follow-up was six months. In group 1 (no tourniquet), the mean Hb dropped 2.8 g/dl from 14.3 ± 1.02 g/dl to 11.5 ± 1.04 g/dl (p = 0.0001), whereas with the tourniquet, the mean decrease was 1.3 g/dl from 14 ± 1 g/dl to 12.7 ± 1.3 g/dl (p = 0.007). This difference was not statistically significant. The mean initial tibial temperature was 35.6°C (. sd. 0.6) and rose with reaming to levels between 36.3°C and 51.6°C. The highest temperatures were obtained with the largest reamers (11 and 12 mm, p = 0.0001) and the most rapid rise with the smallest diameters of medullary canal (8 or 9 mm). The rise of temperature was transient (20s). We were unable to identify any effect of the use of a tourniquet on the temperature achieved. Reamed intramedullary tibial nailing induces a transient elevation of temperature which is directly related to the amount of reaming

Aims. To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Patients and Methods. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D. 3. orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t-test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. Results. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Conclusions. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D. 3. . Cite this article: Bone Joint J 2017;99-B:1520–5

Objectives. The aim of this systematic literature review was to assess the clinical level of evidence of commercially available demineralised bone matrix (DBM) products for their use in trauma and orthopaedic related surgery. Methods. A total of 17 DBM products were used as search terms in two available databases: Embase and PubMed according to the Preferred Reporting Items for Systematic Reviews and Meta Analyses statement. All articles that reported the clinical use of a DBM-product in trauma and orthopaedic related surgery were included. Results. The literature search resulted in 823 manuscripts of which 64 manuscripts met the final inclusion criteria. The included manuscripts consisted of four randomised controlled trials (level I), eight cohort studies (level III) and 49 case-series (level IV). No clinical studies were found for ten DBM products, and most DBM products were only used in combination with other grafting materials. DBM products were most extensively investigated in spinal surgery, showing limited level I evidence that supports the use Grafton DBM (Osteotech, Eatontown, New Jersey) as a bone graft extender in posterolateral lumbar fusion surgery. DBM products are not thoroughly investigated in trauma surgery, showing mainly level IV evidence that supports the use of Allomatrix (Wright Medical, London, United Kingdom), DBX (DePuy Synthes, Zuchwil, Switzerland), Grafton DBM, or OrthoBlast (Citagenix Laval, Canada) as bone graft extenders. Conclusions. The clinical level of evidence that supports the use of DBM in trauma and orthopaedic surgery is limited and consists mainly of poor quality and retrospective case-series. More prospective, randomised controlled trials are needed to understand the clinical effect and impact of DBM in trauma and orthopaedic surgery. Cite this article: J. van der Stok, K. A. Hartholt, D. A. L. Schoenmakers, J. J. C. Arts. The available evidence on demineralised bone matrix in trauma and orthopaedic surgery: A systemati c review. Bone Joint Res 2017;6:423–432. DOI: 10.1302/2046-3758.67.BJR-2017-0027.R1