Advice

Clinical and technical evidence

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

This briefing summarises 5 studies. The studies include a total of 13 people. One of these studies has been published in a peer-reviewed journal (Lavini et al. 2017). One study is in abstract form. Moerenhout and Borens (2016) was presented at the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) conference in 2016 and subsequently published on their website. Three case reports in poster format have been published on the company's website.

Table 1 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

The evidence is very limited in quantity; none of the reports are from the UK, which may limit the generalisability of the findings to the NHS. However, the type of injuries in individual patients selected to have fixation using the device may not differ substantially from those seen in NHS practice.

In general, the evidence suggests that the Galaxy UNYCO can give effective temporary fixation for tibial and ankle fractures; however, there is no direct comparative evidence to determine if patient outcomes would be different to those having other forms of fixation, such as bicortical fixation.

Table 1 Summary of selected studies

Lavini et al. (2017)

Study size, design and location

9 people with ankle fracture dislocations.

Prospective observational study.

Location: Italy.

Intervention and comparator(s)

Galaxy UNYCO.

Key outcomes

Temporary reduction and stabilisation was achieved for all fractures with a correct implant placement. From a total of 34 monocortical screws implanted, CT revealed 4 screws non-optimally positioned, including 2 screw tips penetrating the intramedullary canal more than 2 mm.

Time from incision for the first pin insertion until Galaxy UNYCO definitive stabilisation had been achieved was no more than 10 minutes in all cases.

Open reduction and internal fixation was on average done 8.17 days following Galaxy UNYCO fixation and the average length of stay was 13.30 days.

1 patient had a superficial pin site infection.

Strengths and limitations

Effectiveness data provide some real world insight into the Galaxy UNYCO system's ability to treat ankle fracture dislocations, but there was no comparator. Results suggested that Galaxy UNYCO can be used under a local anaesthetic. Authors commented that Galaxy UNYCO was a feasible intervention for people having anticoagulant therapy.

Moerenhout and Borens (2016)

Study size, design and location

1 person with tibia fracture (AO Foundation type 42‑A2 10 cm above the tibiotalar joint).

Case study (abstract only).

Location: Switzerland.

Intervention and comparator(s)

Galaxy UNYCO.

Key outcomes

Definitive fixation by nailing was made easier because the external fixation system did not have to be removed before the nailing. There was no perioperative complication. The post-operative radiographic and clinical controls gave satisfactory results.

Strengths and limitations

Effectiveness data provides some real world insight into the ability of the Galaxy UNYCO system to treat a tibia fracture; however, this was a single case study with no comparator. Detail was limited because of the abstract-only publication.

Company case report 1

Study size, design and location

17-year-old female with a right femur and tibia fracture because of a high-energy motorcycle accident.

Case study (poster).

Location: Germany.

Intervention and comparator(s)

Galaxy UNYCO.

Key outcomes

Because there was an infection in the tibia, using the Galaxy UNYCO helped optimal bone recovery because the medullary canal was free of any foreign material (bicortical bone screws). Three weeks later, internal fixation was performed. At 5‑month follow‑up, the fracture was progressing well with no problems or complications reported.

Strengths and limitations

Single case study in poster presentation form only, published on company website.

Company case report 2

Study size, design and location

23-year-old male with a simple oblique fracture of the tibia and fibula because of jumping from a 4 m height.

Case study (poster).

Location: Switzerland.

Intervention and comparator(s)

Galaxy UNYCO.

Key outcomes

The Galaxy UNYCO system was used because of the risk of soft tissue necrosis and application time was 27 minutes. Twelve days later, internal fixation was done. At 3‑month follow‑up, the patient reported walking without pain and no complications.

Strengths and limitations

Single case study in poster presentation form only, published on company website.

Company case report 3

Study size, design and location

45-year-old male with a tibia and ankle fracture because of a motorcycle accident.

Case study (poster).

Location: Italy.

Intervention and comparator(s)

Galaxy UNYCO.

Key outcomes

The surgeon initially opted for a skeletal traction treatment. However, because of the worsening condition of the soft tissue, a nail could not be inserted. Therefore the Galaxy UNYCO system was used to allow stabilisation and healing of the soft tissue injuries. The Galaxy UNYCO system was applied in 15 minutes. Three weeks later, an internal fixation procedure took place. At 5‑month follow‑up, the fracture had healed and there was significant improvement of the soft tissue injuries. The patient was able to walk without pain and no complications were reported.

Strengths and limitations

Single case study in poster presentation form only, published on company website.

Recent and ongoing studies