Eight consecutive patients with significant malalignment of the lower limb were included in the study. Pre-operative CT scans of the affected limb and the normal contra-lateral side were obtained and 3D models of the patient's anatomy were created, using dedicated software. The healthy contralateral limb was mirrored and geometrically matched to the distal femur or proximal tibia of the healthy side. A virtual opening wedge correction of the affected bone was used to match the geometry of the healthy contralateral bone. Standard lower limb axes measurements confirmed correction of the alignment. Based on the virtual plan, surgical guides were designed to perform the planar osteotomy and achieve the planned wedge opening and hinge axis orientation. The osteotomy was fixed with locking plates and screws. Post-operative assessment included planar X-rays, CT-scan and full leg standing X-rays.

One three-planar, three bi-planar and four single-plane osteotomies were performed. Maximum weightbearing mechanical femoro-tibial coronal malalignment varied between 7° varus and 14° valgus (mean 7.6°, SD 3.1). Corrective angles varied from 7°–15°(coronal), 0°–13°(sagittal) and 0°–23°(horizontal). The maximum deviation between the planned pre-operative wedge angle and the executed post-operative wedge angle was 1° in the coronal, sagittal and horizontal plane. The desired mechanical femorotibial axis on full-leg standing X-rays was achieved in 6 patients. Two patients were undercorrected by 1° and 2° respectively.

Background

Osteotomies around the knee have been used to correct lower limb mal-alignment for over 50 years. The procedure is technically demanding and carries specific risks of neurovascular injury, incorrect planning and execution, and insufficient fixation. In recent years, with the advent of locking plates, fixation techniques have improved significantly but the correct planning and execution of the operation remains difficult. Despite the availability of CT and MRI 3D imaging, surgical planning is still traditionally performed on 2D plain X-rays [1]. Especially with multi-planar deformities, this technique is prone to error. The aim of this clinical pilot study is to evaluate the feasibility of virtual pre-operative three-dimensional planning and correct execution of osteotomies around the knee with the aid of patient specific surgical guides and locking plates.

Introduction

Osteotomies around the knee are traditionally templated on 2D plain X-rays. Results are often inaccurate and inconsistent and multiplanar ostetomies are hard to perform. The aim of this study is to evaluate the feasibility and accuracy of virtual three-dimensional CT-based planning and correct execution of osteotomies around the knee with the aid of patient specific surgical guides and locking plates.

Introduction

Autologous chondrocyte implantation presents a viable alternative to microfracture in the repair of damaged articular cartilage of the knee; however, outcomes for patellar lesions have been less encouraging. ChondroCelect (CC) is an innovative, advanced cell therapy product consisting of autologous cartilage cells expanded ex vivo through a highly controlled and consistent manufacturing process.

The understanding of rotational alignment of the distal femur is essential in total knee replacement to ensure that there is correct placement of the femoral component. Many reference axes have been described, but there is still disagreement about their value and mutual angular relationship. Our aim was to validate a geometrically-defined reference axis against which the surface-derived axes could be compared in the axial plane. A total of 12 cadaver specimens underwent CT after rigid fixation of optical tracking devices to the femur and the tibia. Three-dimensional reconstructions were made to determine the anatomical surface points and geometrical references. The spatial relationships between the femur and tibia in full extension and in 90° of flexion were examined by an optical infrared tracking system.

After co-ordinate transformation of the described anatomical points and geometrical references, the projection of the relevant axes in the axial plane of the femur were mathematically achieved. Inter-and intra-observer variability in the three-dimensional CT reconstructions revealed angular errors ranging from 0.16° to 1.15° for all axes except for the trochlear axis which had an interobserver error of 2°. With the knees in full extension, the femoral transverse axis, connecting the centres of the best matching spheres of the femoral condyles, almost coincided with the tibial transverse axis (mean difference −0.8°, SD 2.05). At 90° of flexion, this femoral transverse axis was orthogonal to the tibial mechanical axis (mean difference −0.77°, SD 4.08). Of all the surfacederived axes, the surgical transepicondylar axis had the closest relationship to the femoral transverse axis after projection on to the axial plane of the femur (mean difference 0.21°, SD 1.77). The posterior condylar line was the most consistent axis (range −2.96° to − 0.28°, SD 0.77) and the trochlear anteroposterior axis the least consistent axis (range − 10.62° to +11.67°, SD 6.12). The orientation of both the posterior condylar line and the trochlear anteroposterior axis (p = 0.001) showed a trend towards internal rotation with valgus coronal alignment.

A comparative kinematic study was carried out on six cadaver limbs, comparing tibiofemoral kinematics in five different conditions: unloaded, under a constant 130 N ankle load with a variable quadriceps load, with and without a constant 50 N medial and lateral hamstrings load. Kinematics were described as translation of the projected centers of the medial (MFT) and lateral femoral condyles (LFT) in the horizontal plane of the tibia, and tibial axial rotation (TR) as a function of flexion angle. In passive conditions, the tibia rotated internally with increasing flexion, to an average of −16° (range −12/−20°, SD 3.0°). Between 0 – 40° flexion, the medial condyle translated forwards 4 mm (range 0.8/5.5 mm, SD 2.5 mm), followed by a gradual posterior translation, totaling −9 mm (range −5.8/−18.5 mm, SD 4.9 mm) between 40° – 140° flexion. The lateral femoral condyle translated posteriorly with increasing flexion completing −25 mm (range −22.6 – −28.2 mm, SD 2.5 mm). Dynamic, loaded measurements were carried out in a knee rig. Under a fixed ankle load of 130 N and variable quadriceps loading, tibial rotation was inverted, mean TR 4.7° (range −3.3°/11.8° SD 5.4°), MFT −0.5 mm (range = −4.3/2.4 mm, SD = 2.4 mm), LFT 3.3 mm (range = −3.6/10.6 mm, SD = 5.1 mm). As compared to the passive condition, all these excursions were significantly different: p=0.015, p=0.013, and p=0.011 for TR, MFT and LFT respectively. Adding medial and lateral hamstrings force of 50N each, reduced TR, MFT and LFT significantly as compared to the passive condition. In general, loading the knee with hamstrings and quadriceps reduces rotation and translation as compared to the passive condition. Lateral hamstring action is more influential on knee kinematics than medial hamstrings action.

Methodology: A retrospective review based on a prospective database was performed on 146 consecutive revision TKA’s. An independent observer measured clinical outcomes using the Knee Society Knee (KS) and Function Score (FS). X-ray evaluation, including rating of radiolucent lines, tibiofemoral and patellofemoral alignment, was carried out by an independent radiologist. ANOVA was used for statistical analysis, with significance set at p≤0.05 (SPSS version 15.0). Post-hoc Bonferroni testing was carried out for single variables including primary cause of failure, age at revision surgery, time span between index operation and revision, type of index operation, partial or total revision and the performance of a tuberosity osteotomy.

Results: 146 files were available in 135 patients. 16 patients deceased (17 knees) during the follow-up period and 2 patients (2 knees) were lost to follow-up. 117 patients (127 knees) were available for evaluation. Age at revision surgery averaged 67.7 years (range 32.3–88.1). Mean follow-up time was 4.5 years (range 1–14). Patients had revision TKA between 51 days and 16.1 years (average 4.7 years) after the index TKA. 54% of the early revisions were due to infection and instability, 55% of late revisions were caused by polyethylene-wear and loosening. The mean postoperative KS was 70.8 with a mean improvement of 43.2 points as compared to pre-operative. The mean postoperative FS was 52.9 with a mean improvement of 25.4 points. Grouping outcomes according to cause of failure of the index TKA gave the following ranking from better to worse, without being significant: wear (n=15; KS 80.8; range 43–99, SD 17.5), loosening (n=44; KS 75.8; range 15–100, SD=21.2), malalignment (n=19; KS 70.0; range 9–95, SD 25.9), instability (n=33; KS 68.2; range 5–100, SD 24.1), others (n=16; KS 66.7; range 10–100, SD 25.9), and infection (n=21; KS 64.2; range 3–100, SD 31.7). Survivorship at 5 years was 90.0% (CI 86.4% –93.6%), at 10 years 84,6% (CI 77.0% –92.3%) and at 14 years 84,6% (CI 37.7% –131.6%). Significant better outcomes were seen with late revisions, index operation being partial knee replacement and older age at revision. More failures (p=0.002) were seen with early revisions. In 32.6% of the patients radiolucent lines of ≥1 mm were observed. Points were granted with the use of a Radiolucency Scoring Scheme. Patients with less than 4 points (n=87, mean KS 71.2) had better outcomes than patients with 4 or more points (n=8, mean KS 56.4). 87% of patients were aligned within 4° of mechanical axis.

Conclusion:

Outcomes of revision TKA are inferior to primary TKA.

Purpose: Long-term follow-up was to determine clinical benefit of ChondroCelect (CC) in the repair of full-thickness femoral cartilage lesions as compared to microfracture (MF).

Methods: In a randomized controlled clinical trial CC (n=57) was compared to MF (n=61) in patients aged 18 to 50 years with single ICRS grade III/IV symptomatic cartilage defects of the femoral condyles. Clinical improvement was measured up to 36 months using the KOOS (Knee injury and Osteoarthritis Outcome Score). Safety was monitored throughout the study.

Results: At baseline, KOOS was comparable between treatment groups (Mean ± SD: CC, 56.30 ± 13.61 and MF, 59.53 ± 14.95). Improvement from baseline in adjusted mean ± SE for the Overall KOOS was 21.25 ± 3.60 for the CC group vs. 15.83 ± 3.48 for the MF group at 36 months. When using the mixed linear model analysis at 36 months, statistically significantly greater improvements were demonstrated in the CC group vs. the MF group in change from baseline for the overall KOOS (D 7.60%, P = 0.018), as well as in 4 of 5 KOOS domains (activities of daily living, pain, symptoms/stiffness, and quality of life). Percentages of treatment responders were 83% (n = 34/41) vs. 62% (n = 31/50) based on the KOOS for CC and MF groups, respectively. Two (3.9%) patients in the CC group and 7 (11.5%) patients in the MF group underwent a re-intervention and were therefore considered treatment failures. Both treatments were well tolerated and the proportion of patients reporting AEs diminished over time, indicating stabilization of the patients’ condition.

Conclusions: Implantation of ChondroCelect in the treatment of articular cartilage defects of the femoral condyles shows superior clinical benefit at 36 months vs. microfracture. Structural superiority in favour of the ChondroCelect group was previously demonstrated at 1 year follow up.

Introduction: High-flexion (HF) TKA designs were introduced in order to achieve greater flexion than with conventional TKA designs. Although early clinical results are promising, recent literature raises concerns about fixation and risk for early loosening of the femoral component during high demanding activities. This study’s aim was to measure the loosening force of the femoral component of several PS-TKA designs in a deep flexion configuration.

Methods: The loosening force of the femoral component of ten contemporary PS-TKAs, including five HF and five conventional designs from the major orthopaedic companies were evaluated. To simulate a deep flexion configuration, each TKA was implanted in a femoral bone model and placed in a loading frame in 135° of flexion, with the tibia vertically. Loosening of the femoral component was induced by raising the tibial insert with constant displacement rate, maintaining the same flexion angle. The resisting force was recorded continuously. A stereo-photogrammetric system registered the relative motion between the femoral component and the bone model. The loosening force was determined when a gap of 2 mm was observed. The influence of pegs on the loosening force was also investigated.

Results: Generally, conventional femoral designs required higher forces before loosening occurred compared to HF designs (p< 0.001). In the group of the HF designs there was a statistically significant difference between the designs (p=0.015) due to the shape of the internal box cut. For some designs, the presence of pegs induced a statistically significant change in loosening force.

Discussion and Conclusion: Several design characteristics of the femoral component can alter its resistance to loosening. In this in vitro study, it was shown that the shape of the internal box cut and the presence of pegs, as well as the geometry of the pegs, are important factors for the loosening force. In the group of the HF components there was a statistically significant difference between the designs with an open and a closed box.

Introduction: Meniscal injuries are common and a potential source of osteoarthritis of the knee. This has led to the development of techniques to repair meniscal tears. The goal of this study was to look at the independent variables that have an influence on the outcome and identify factors that might improve future clinical results.

Method: A total of 119 meniscal repairs were included in this study and evaluated at minumum 72 months postoperatively (range 72–86). Meniscal repair was done by an arthroscopically assisted technique: inside-out, all-inside or by a combination of both techniques. Patients with menisci repaired were clinically evaluated. We performed examinations using the International Knee Documentation Committee (IKDC) form and the Lysholm score. Radiological analysis of the knees was done by means of the Ahlback classification pre- and postoperatively. Variables that were analyzed were age, gender, type of repair, chronicity of the lesion, zone of injury, morphology of the tear, involvement of the anterior cruciate ligament (ACL), and the compartment involved. Statistical analysis was done by means of logistic regression.

Results: The overall clinical success rate for meniscal repair was 74.0%. In 73.1% of the cases, the mensiscal injury was associated with an injury of the ACL. Patients with an associated ACL injury had a better chance for a successfull outcome, but this was only significantly when the ACL injury was repaired (p< 0.05). There was no difference between the male and female patients regarding outcome. A delay in treatment for 6 weeks or more resulted in significantly worse results (p< 0.001). Younger patients had significantly better outcome results (p< 0.05). Better results were obtained when the inside-out technique was used for meniscal repair (p< 0.05).

Discussion: Our data confirm the good outcome results of meniscal repair. In our hands, a meniscal repair has the highest likelihood of success in young patients, with a concomitant ACL injury that is repaired at the same time. Better outcome scores were observed when the inside-out technique was used and when menisci where repaired within 6 weeks of the initial injury.

Purpose: A three-year evaluation of long-term clinical efficacy of Characterized Chondrocyte Implantation (CCI) compared to microfracture (MF), in the repair of symptomatic cartilage defects of the femoral condyles at 36 months post-surgery.

Materials and Methods: In a prospective, randomized, controlled, multicenter trial, CCI was compared to MF in patients aged 18–50 years with a single symptomatic ICRS grade III–IV lesion of the knee. Clinical outcome was measured 36 months after surgery by means of the KOOS, VAS for pain and ARS, with a non-inferiority margin preset at 9 % points for KOOS and VAS. Furthermore, response to treatment and progression of knee symptoms were assessed. Treatment failure was monitored throughout the study.

Results: Improvement from baseline was higher in the CCI group (N = 41) compared to the MF group (N = 49) for all clinical outcome parameters. Mean improvement from baseline for Overall KOOS was 22.14 vs. 14.48, respectively, with VAS and ARS scores revealing a similar trend. Responder analysis showed 83% of the patients treated with CCI improving vs. 61% after MF. Additionally, we observed a shift in the proportion of knee symptoms over time (52% vs. 35% of asymptomatic knees at 36 months compared to 2% vs. 8% at baseline in the CCI and MF group respectively). At 36 months, failure rates were low in both groups (n=2 in CCI vs. n=7 in MF).

Conclusions: Previous data have described a superior structural repair after CCI compared to MF at 1 year post-surgery. Continued clinical improvement as well as a favorable responder analysis was demonstrated for CCI compared to MF at 36 months.

The purpose of the current study was to compare mid-term outcomes of posterior cruciate retaining(CR) versus posterior cruciate substituting (PS)procedures, using the Genesis II total knee arthroplasty (TKA) system(Smith and Nephew, Memphis TN). Ninety nine CR and 93 PS TKA’s were analysed in this prospective, randomised, clinical trial. Surgeries were performed at seven medical centres by participating surgeons. Clinical outcomes (Knee Society Score, Range of Motion, WOMAC, SF 12 : and radiographic findings), in addition to postoperative complications, were evaluated with a minimum follow-up of five years. Following data analysis, there were no Significant differences in patient demographics or pre-operative clinical measures between the two groups. At the latest follow-up interval, no Significant differences were found between the CR and PS groups with regard to functional assessment, patient satisfaction or post-operative complications. However the PS group did display statistically Significant improvements in range of motion when compared with the CR group. The results of this investigation would suggest that while comparable in regards to supporting good clinical outcomes, the PS Genesis II design does appear to support significantly improved post-operative range of motion when compared with the CR design

Purpose: As a one-step surgical procedure, microfracture is frequently considered to be technically easier and associated with less postoperative morbidity than autologous chondrocyte implantation (ACI), which involves both arthrotomy and arthroscopy and therefore safety was assessed in patients with symptomatic cartilage lesions of the knee treated with characterized chondrocyte implantation (CCI) or microfracture.

Methods: CCI (n=57) was compared to microfracture (n=61) in patients with grade III–IV symptomatic cartilage defects of the femoral condyles in a Phase III, prospective, multi-center, randomized, controlled trial. Safety assessments included adverse events (AEs), physical examination, vital signs, hematology and clinical chemistry.

Results: At 18 months post-surgery, similar proportions of patients experienced AEs in the CCI (88%) and microfracture (82%) groups; 67% and 59%, respectively, experienced AEs considered treatment related. The AE profile was generally similar between groups, with no significant difference for hypertrophy, although significantly more CCI-treated patients had joint swelling (19% versus 4.9%; p=0.022) and treatment-related joint crepitation (12% versus 1.6%; p=0.028). Although the proportion of patients with severe AEs was similar for CCI (12%) and microfracture (13%), slightly more microfracture-treated patients experienced serious (life-threatening or requiring hospitalization) AEs (13% versus 8.8%). No patients discontinued due to AEs or died during the study.

Conclusion: Contrary to general opinion, the two-step CCI procedure, involving arthroscopy followed by arthrotomy, has a similar safety profile to that of microfracture, a one-step arthroscopic procedure, for treating cartilage lesions of the knee.

Purpose: This study compared the efficacy and safety of Characterized Chondrocyte Implantation (CCI) to microfracture in the repair of symptomatic cartilage defects of the femoral condyle.

Methods: CCI (n=51) was compared to microfracture (n=61) in patients with grade III–IV symptomatic cartilage defects of the femoral condyles in a prospective, multicenter, randomized, controlled trial. Structural repair was assessed at 1 year by histopathologists blinded to the treatment using

computerized histomorphometry and

Results: CCI resulted in better structural repair than microfracture at 1 year post-treatment, as assessed by histomorphometry (p=0.003) and overall histology (p=0.012). Structural repair parameters relating to chondrocyte phenotype and tissue structure were also superior with CCI. Noninferiority of CCI was demonstrated for clinical outcome at 12–18 months, and both treatments were generally well tolerated.

Conclusion: At 1 year post-treatment, CCI resulted in superior tissue repair compared to microfracture. Short-term clinical outcome after 12–18 months was similar for both treatments, as was the safety profile. The superior structural repair achieved with CCI may lead to improved long-term clinical benefits.

Aims: The aim of the study was to determine the accuracy of the kinematical determination of the centre of rotation of the hip and to compare the outcome of the Computer assisted surgery (CAS) group versus a control group of patients with conventionally instrumented TKA, in a prospective randomized way. Methods: A prospective, randomized and controlled trial was undertaken with an image based CAS system (ION®), using specific knee software for the GENESIS II®total knee system. Randomization was performed on a consecutive group of 50 primary TKA’s, without exclusion criteria. All computed kinematical centres of rotation of the hip were compared to the anatomic fluoroscopic images. The difference between the kinematical centre of rotation and the anatomic centre of the femoral head was measured in the frontal plane. Coronal alignment was measured on full leg standing films. Validation of the full leg standing films was carried out in comparing the pre-operative measured angle and the computed deformity angle at the beginning of the surgery. Outcome of the CAS group was compared to the conventional group on the following items: tourniquet time, operative time, blood loss, patellar alignment, tibial slope, coronal alignment, range of motion and complications. Results: ACCURACY: The correlation index between pre-op full legs and CAS measured values was excellent: r²=0.997. Difference between kinematical centre of rotation and anatomic centre of the hip: mean deviation between the two points was 1.2 mm (0–4mm), stdv 1.2 mm. This corresponds with a mean angular deviation of 0.17° (0–0.57°). OUTCOME: Tourniquet time: conventional 56 min., CAS 72 min. p=0.002. Operative time: conventional 70 min., CAS 93 min. p< 0.001. Blood loss: conventional 3.3 g/dl, CAS 4 g/dl. Patellar alignment: no tilt > 5°, no subluxation > 3 mm, both groups. Tibial slope: conventional 3.5°, CAS 3°. Post-operative mechanical alignment was between 0 and 2° of deformity for 16 conventional knees, and between 3–4° for 5 conventional knees. In the CAS group, all 21 knees scored between 0° and 2° of mechanical alignment. ROM at 6 weeks: flexion conventional 106°, CAS 105°. Fixed flexion contracture: conventional 2.9, CAS 2.1. Complications: delayed wound healing: conventional 2, CAS 1. Conclusions: Computer assisted kinematical determination of the centre of the hip can be highly accurate. Post-operative coronal alignment in CAS group is excellent, however not significantly better than conventional instrumentation.