Objectives

We hypothesise that a long-term bioresorbable hydrophilic silkworm silk device, the SeriACL(tm) scaffold, can support the development and remodelling of native functional ligament tissue if designed to anticipate the remodelling curve of an ACL graft. This study evaluated the SeriACL scaffold for ACL replacement in a goat model at 3, 6 and 12 months.

The Cartilage Autograft Implantation System (CAIS) is being investigated as a potential alternative surgical treatment to provide chondrocyte-based repair in a single procedure for articular cartilage lesion(s) of the knee. CAIS involves preparation and delivery of mechanically morselized, autologous cartilage fragments uniformly dispersed on a 3-dimensional, bio-absorbable scaffold and fixated in the lesion with bio-absorbable staples. CAIS maintains chondrocyte viability and creates increased surface area, which facilitates the outgrowth of embedded chondrocytes onto the scaffold. A proprietary disposable arthroscopic device for harvesting precisely morselized cartilage tissue is used.

In an EU pilot clinical study involving 5 countries 25 patients were randomized and treated using a 2:1 schema of CAIS:microfracture (MFX). Subjects returned for follow-up visits at 1 and 3 weeks and then 2, 3, 6, 9, 12, 18 and 24 months and were evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Outcomes at each time point were analyzed with Students t-test.

This study showed that CAIS is safe to use. During the first year, the clinical outcome data in both groups were similar. However, at 18 and 24 months we noted that selected outcome measures were different. At 18 months the Sports & Recreation values were 50.6 ± 22.70 and 21.3 ± 33.25 (p=0.016) for CAIS and MFX respectively and at 24 months 52.1 ± 27.9 and 26.7 ± 26.2 (p=0.061) for CAIS and MFX respectively. At these same time points the Quality of Life data were 43.0 ± 27.14 and 27.2 ± 29.11 (p=0.2) for CAIS and MFX respectively (18 months) and 45.1 ± 28.07 and 20.5 ± 21.47 (p=0.062) for CAIS and MFX respectively (24 months).

While some of the data are not significantly different in this pilot study, taken together they do provide evidence to support the initiation of a more robust clinical trial to investigate efficacy.

The Cartilage Autograft Implantation System (CAIS) is being developed as a potential alternative surgical treatment providing chondrocyte-based repair in a single procedure for articular cartilage lesion(s) of the knee. Two pilot clinical studies were conducted to assess safety and initial performance of the CAIS system.

CAIS involves preparation and delivery of mechanically morselized, autologous cartilage uniformly dispersed on a 3-dimensional, bio-absorbable scaffold, and fixated in the defect with bio-absorbable staples. The mechanical fragmentation of cartilage tissue both maintains viability of the chondrocytes and creates increased surface area, which facilitates the outgrowth of embedded chondrocytes onto the scaffold. A proprietary disposable, arthroscopic device for precisely harvesting viable, morselized cartilage tissue was used. Two pilot clinical studies conducted in the EU and US were designed to assess safety and initial performance of the CAIS. The studies treated 53 patients at 10 enrolling sites, with microfracture as a control. Subjects returned for follow-up visits up to 3 years. Subjects were clinically evaluated and interviewed for the occurrence of adverse events and asked to complete clinical outcome questionnaires, Knee Injury and Osteoarthritis Outcome Score (KOOS), regarding disability, function, pain and quality of life. In addition, MRIs were completed at baseline, 3 weeks, and 6, 12, 24, and 36 months.

The instrumentation enabled the successful preparation and fixation of morselized autologous cartilage tissue loaded implant in a single intraoperative setting. The CAIS device has demonstrated short-term safety in subjects treated to date. Preliminary data from the US pilot study at 12 months and EU pilot study at 6 months indicate that CAIS is safe and its performance based on KOOS clinical outcomes show improvement over baseline and comparability to microfracture. Additional data must be analyzed regarding long-term safety and performance.

Aims: To determine the results of Òbiologic þxationÒ with a minimally invasive plating technique using a newly designed low proþle ÒScallopÒ plate in the treatment of pilon fractures. Methods: 17 patients were treated between 1999 and 2001 for a tibial plafond with a newly designed ultra-slim plate. Eleven (65%) were high-energy injuries, two were open. Staged open reduction and þxation of the þbular fracture and application of an External Fixator was performed in 12 cases. As soon as the soft tissues and swelling allowed, the articular surface was reconstructed and anatomically reduced, if necessary through an small incision, and the articular block was þxed to the diaphysis using a medially placed, percutaneously introduced ßat Scallop plate. Time to healing and complications were evaluated. Quality of the results and outcome were graded using the Ankle-Hindfoot-Scale. Results: All patients went on to bony union at an average time of 14.1 weeks. There were no plate failures or loss of þxation/ reduction. Two superþcial wound-healing problems resolved with local wound care. At an average FU of 17 months eight patients (47%) had an excellent, seven (41%) a fair and two (12%) a poor result. The average AHS was 86.1. Conclusions: Based on these initial results, it appears that a minimally invasive surgical technique using a new low proþle plate can decrease soft tissue problems while leading to fracture healing and obtaining results comparable with other more recent series. We believe that this new ÒScallop PlateÒ is appropriate for the treatment of pilon fractures and should be used in conjunction with a staged procedure in the acute trauma setting.

Aims: Nonunions of the distal tibia are difþcult to treat due to the short distal segment, the proximity to the ankle joint and the fragile soft tissue envelope. Intramedullary nailing is an attractive solution as it avoids extensive soft tissue dissection and remains intraosseus, posing little problem for the soft tissues. The purpose of this study was to determine the efþcacy of reamed intramedullary nailing in the treatment of non-unions of the distal one-quarter of the tibia. Methods: Thirty-two patients with nonunions of the distal one-quarter of the tibia were treated by reamed, locked intramedullary nailing. Prior treatments included casting as well as intramedullary or extramedullary þxation techniques. No patient had signs of an active infection at the time of surgery. Time to union, correction of deformity and complications including infection and reoperation were examined. Results: Twenty-nine out of thirty-two patients achieved union at an average of 3.5 months after surgery. Of the remaining three, two patients united rapidly after dynamisation and one after exchange nailing. Deformity was corrected to a maximum of four degrees in all planes. Four patients had positive intraoperative culture, and only two required removal of the nail after achieving union to eradicate infection. There were no cases of chronic osteomyelitis after the procedure. Conclusions: Reamed, locked intramedullary nailing is a reliable and safe procedure in the treatment of nonunions in the distal one-quarter of the tibia. It allows for excellent correction of deformity, which is an essential component of the procedure.