Role of joint distraction in osteoarthritis of the knee: Basic science, principles and outcomes.

The burden of knee osteoarthritis (OA) is increasing worldwide. Advanced tibiofemoral joint OA in young patients is particularly a problem with inferior results seen with total knee arthroplasty in this patient population. Knee joint distraction (KJD) has been evaluated recently as a joint preserving procedure for young patients with advanced tibiofemoral osteoarthritis, to delay the need for a primary total knee arthroplasty (TKA). This will decrease the risk for revision TKA later in life. KJD temporarily unloads the knee joint and keeps the tibia and femur separated over a course of 6 weeks. Outcomes of KJD appear promising. Through this article, the authors hope to share from their collective experience as well as the available literature on the basic science, principles of surgery and outcomes of KJD.

Comparison between 2D radiographic weight-bearing joint space width and 3D MRI non-weight-bearing cartilage thickness measures in the knee using non-weight-bearing 2D and 3D CT as an intermediary.

BACKGROUND: In knee osteoarthritis, radiographic joint space width (JSW) is frequently used as a surrogate marker for cartilage thickness; however, longitudinal changes in radiographic JSW have shown poor correlations with those of magnetic resonance imaging (MRI) cartilage thickness. There are fundamental differences between the techniques: radiographic JSW represents two-dimensional (2D), weight-bearing, bone-to-bone distance, while on MRI three-dimensional (3D) non-weight-bearing cartilage thickness is measured. In this exploratory study, computed tomography (CT) was included as a third technique, as it can measure bone-to-bone under non-weight-bearing conditions. The objective was to use CT to compare the impact of weight-bearing versus non-weight-bearing, as well as bone-to-bone JSW versus actual cartilage thickness, in the knee. METHODS: Osteoarthritis patients (n = 20) who were treated with knee joint distraction were included. Weight-bearing radiographs, non-weight-bearing MRIs and CTs were acquired before and 2 years after treatment. The mean radiographic JSW and cartilage thickness of the most affected compartment were measured. From CT, the 3D median JSW was calculated and a 2D projectional image was rendered, positioned similarly and measured identically to the radiograph. Pearson correlations between the techniques were derived, both cross-sectionally and longitudinally. RESULTS: Fourteen patients could be analyzed. Cross-sectionally, all comparisons showed moderate to strong significant correlations (R = 0.43-0.81; all p < 0.05). Longitudinal changes over time were small; only the correlations between 2D CT and 3D CT (R = 0.65; p = 0.01) and 3D CT and MRI (R = 0.62; p = 0.02) were statistically significant. CONCLUSION: The poor correlation between changes in radiographic JSW and MRI cartilage thickness appears primarily to result from the difference in weight-bearing, and less so from measuring bone-to-bone distance versus cartilage thickness.

Changes in Cartilage Thickness and Denuded Bone Area after Knee Joint Distraction and High Tibial Osteotomy-Post-Hoc Analyses of Two Randomized Controlled Trials.

High tibial osteotomy (HTO) and knee joint distraction (KJD) are joint-preserving treatments that unload the more affected compartment (MAC) in knee osteoarthritis. This post-hoc study compares two-year cartilage-thickness changes after treatment with KJD vs. HTO, and identifies factors predicting cartilage restoration. Patients indicated for HTO were randomized to KJD (KJDHTO) or HTO treatment. Patients indicated for total knee arthroplasty received KJD (KJDTKA). Outcomes were the MRI mean MAC cartilage thickness and percentage of denuded bone area (dABp) change two years after treatment, using radiographic joint space width (JSW) as the reference. Cohen's d was used for between-group effect sizes. Post-treatment, KJDHTO patients (n = 18) did not show significant changes. HTO patients (n = 33) displayed a decrease in MAC cartilage thickness and an increase in dABp, but an increase in JSW. KJDTKA (n = 18) showed an increase in MAC cartilage thickness and JSW, and a decrease in dABp. Osteoarthritis severity was the strongest predictor of cartilage restoration. Kellgren-Lawrence grade ≥3 showed significant restoration (p < 0.01) after KJD; grade ≤2 did not. Effect sizes between severe KJD and HTO patients were large for MAC MRI cartilage thickness (d = 1.09; p = 0.005) and dABp (d = 1.13; p = 0.003), but not radiographic JSW (d = 0.28; p = 0.521). This suggests that in knee osteoarthritis patients with high disease severity, KJD may be more efficient in restoring cartilage thickness.

Knee Joint Distraction Compared with High Tibial Osteotomy and Total Knee Arthroplasty: Two-Year Clinical, Radiographic, and Biochemical Marker Outcomes of Two Randomized Controlled Trials.

OBJECTIVE: Both, knee joint distraction (KJD) and high tibial osteotomy (HTO) are joint-preserving surgeries that postpone total knee arthroplasty (TKA) in younger osteoarthritis (OA) patients. Here we evaluate the 2-year follow-up of KJD versus TKA and KJD versus HTO in 2 noninferiority studies. DESIGN: Knee OA patients indicated for TKA were randomized to KJD (n = 20; KJDTKA) or TKA (n = 40). Medial compartmental knee OA patients considered for HTO were randomized to KJD (n = 23; KJDHTO) or HTO (n = 46). Patient-reported outcome measures were assessed over 2 years of follow-up. The radiographic joint space width (JSW) was measured yearly. In the KJD groups, serum-PIIANP and urinary-CTXII levels were measured as collagen type-II synthesis and breakdown markers. It was hypothesized that there was no clinically important difference in the primary outcome, the total WOMAC, when comparing KJD with HTO and with TKA. RESULTS: Both trials were completed, with 114 patients (19 KJDTKA; 34 TKA; 20 KJDHTO; 41 HTO) available for 2-year analyses. At 2 years, the total WOMAC score (KJDTKA: +30.4 [95% CI 23.0-37.9] points; TKA: +42.4 [95% CI 38.1-46.8]; KJDHTO: +21.6 [95% CI 13.8-29.4]; HTO: +29.2 [95% CI 23.6-34.8]; all: P < 0.05) and radiographic minimum JSW (KJDTKA: +0.9 [95% CI 0.2-1.6] mm; KJDHTO: +0.9 [95% CI 0.5-1.4]; HTO: +0.6 [95% CI 0.3-0.9]; all: P < 0.05) were still increased for all groups. The net collagen type-II synthesis 2 years after KJD was increased (P < 0.05). Half of KJD patients experienced pin tract infections, successfully treated with oral antibiotics. CONCLUSIONS: Sustained improvement of clinical benefit and (hyaline) cartilage thickness increase after KJD is demonstrated. KJD was clinically noninferior to HTO and TKA in the primary outcome.

Knee Joint Distraction as Treatment for Osteoarthritis Results in Clinical and Structural Benefit: A Systematic Review and Meta-Analysis of the Limited Number of Studies and Patients Available.

OBJECTIVE: Knee joint distraction (KJD) is a joint-preserving osteoarthritis treatment that may postpone a total knee arthroplasty (TKA) in younger patients. This systematic review and meta-analysis evaluates short- and long-term clinical benefit and tissue structure changes after KJD. DESIGN: MEDLINE, EMBASE, and Web of Science were searched for eligible clinical studies evaluating at least one of the primary parameters: WOMAC, VAS-pain, KOOS, EQ5D, radiographic joint space width or MRI cartilage thickness after KJD. Random effects models were applied on all outcome parameters and outcomes were compared with control groups found in the included studies. RESULTS: Eleven articles reporting on 7 different KJD cohorts with in total 127 patients and 5 control groups with multiple follow-up moments were included, of which 2 were randomized controlled trials. Significant improvements in all primary parameters were found and benefit lasted up to at least 9 years. Overall, outcomes were comparable with control groups, including high tibial osteotomy, although TKA showed better clinical response. CONCLUSIONS: Current, still limited, evidence shows KJD causes clear benefit in clinical and structural parameters, both short- and long-term. Longer follow-up with more patients is necessary, to validate outcome and to potentially improve patient selection for this intensive treatment. Thus far, for younger knee osteoarthritis patients, KJD may be an option to consider.

Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.

OBJECTIVES: Knee joint distraction (KJD) has been evaluated as a joint-preserving treatment to postpone total knee arthroplasty in knee osteoarthritis patients in three clinical trials. Since 2014 the treatment is used in regular care in some hospitals, which might lead to a deviation from the original indication and decreased treatment outcome. In this study, baseline characteristics, complications and clinical benefit are compared between patients treated in regular care and in clinical trials. METHODS: In our hospital, 84 patients were treated in regular care for 6 weeks with KJD. Surgical details, complications, and range of motion were assessed from patient hospital charts. Patient-reported outcome measures were evaluated in regular care before and one year after treatment. Trial patients (n = 62) were treated and followed as described in literature. RESULTS: Patient characteristics were not significantly different between groups, except for distraction duration (regular care 45.3±4.3; clinical trials 48.1±8.1 days; p = 0.019). Pin tract infections were the most occurring complication (70% regular care; 66% clinical trials), but there was no significant difference in treatment complications between groups (p>0.1). The range of motion was recovered within a year after treatment for both groups. WOMAC questionnaires showed statistically and clinically significant improvement for both groups (both p<0.001 and >15 points in all subscales) and no significant differences between groups (all differences p>0.05). After one year, 70% of patients were responders (regular care 61%, trial 75%; p = 0.120). Neither regular care compared to clinical trial, nor any other characteristic could predict clinical response. CONCLUSIONS: KJD as joint-preserving treatment in clinical practice, to postpone arthroplasty for end-stage knee osteoarthritis patient below the age of 65, results in an outcome similar to that thus far demonstrated in clinical trials. Longer follow-up in regular care is needed to test whether also long-term results remain beneficial and comparable to trial data.

Cartilage Quality (dGEMRIC Index) Following Knee Joint Distraction or High Tibial Osteotomy.

OBJECTIVE: High tibial osteotomy (HTO) and knee joint distraction (KJD) are treatments to unload the osteoarthritic (OA) joint with proven success in postponing a total knee arthroplasty (TKA). While both treatments demonstrate joint repair, there is limited information about the quality of the regenerated tissue. Therefore, the change in quality of the repaired cartilaginous tissue after KJD and HTO was studied using delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC). DESIGN: Forty patients (20 KJD and 20 HTO), treated for medial tibiofemoral OA, were included in this study. Radiographic outcomes, clinical characteristics, and cartilage quality were evaluated at baseline, and at 1- and 2-year follow-up. RESULTS: Two years after KJD treatment, clear clinical improvement was observed. Moreover, a statistically significant increased medial (Δ 0.99 mm), minimal (Δ 1.04 mm), and mean (Δ 0.68 mm) radiographic joint space width (JSW) was demonstrated. Likewise, medial (Δ 1.03 mm), minimal (Δ 0.72 mm), and mean (Δ 0.46 mm) JSW were statistically significantly increased on radiographs after HTO. There was on average no statistically significant change in dGEMRIC indices over two years and no difference between treatments. Yet there seemed to be a clinically relevant, positive relation between increase in cartilage quality and patients' experienced clinical benefit. CONCLUSIONS: Treatment of knee OA by either HTO or KJD leads to clinical benefit, and an increase in cartilage thickness on weightbearing radiographs for over 2 years posttreatment. This cartilaginous tissue was on average not different from baseline, as determined by dGEMRIC, whereas changes in quality at the individual level correlated with clinical benefit.

Prognostic Factors for Return to Sport After High Tibial Osteotomy: A Directed Acyclic Graph Approach.

BACKGROUND: High tibial osteotomy (HTO) is increasingly used in young and physically active patients with knee osteoarthritis. These patients have high expectations, including return to sport (RTS). By retaining native knee structures, a return to highly knee-demanding activities seems possible. However, evidence on patient-related outcomes, including RTS, is sparse. Also, time to RTS has never been described. Furthermore, prognostic factors for RTS after HTO have never been investigated. These data may further justify HTO as a surgical alternative to knee arthroplasty. PURPOSE: To investigate the extent and timing of RTS after HTO in the largest cohort investigated for RTS to date and to identify prognostic factors for successful RTS. STUDY DESIGN: Case-control study; Level of evidence, 3. METHODS: Consecutive patients with HTO, operated on between 2012 and 2015, received a questionnaire. First, pre- and postoperative sports participation questions were asked. Also, time to RTS, sports level and frequency, impact level, the presymptomatic and postoperative Tegner activity score (1-10; higher is more active), and the postoperative Lysholm score (0-100; higher is better) were collected. Finally, prognostic factors for RTS were analyzed using a logistic regression model. Covariates were selected based on univariate analysis and a directed acyclic graph. RESULTS: We included 340 eligible patients of whom 294 sufficiently completed the questionnaire. The mean follow-up was 3.7 years (± 1.0 years). Out of 256 patients participating in sports preoperatively, 210 patients (82%) returned to sport postoperatively, of whom 158 (75%) returned within 6 months. We observed a shift to participation in lower-impact activities, although 44% of reported sports activities at final follow-up were intermediate- or high-impact sports. The median Tegner score decreased from 5.0 (interquartile range [IQR], 4.0-6.0) presymptomatically to 4.0 (IQR, 3.0-4.0) at follow-up (P < .001). The mean Lysholm score at follow-up was 68 (SD, ± 22). No significant differences were found between patients with varus or valgus osteoarthritis. The strongest prognostic factor for RTS was continued sports participation in the year before surgery (odds ratio, 2.81; 95% CI, 1.37-5.76). CONCLUSION: More than 8 of 10 patients returned to sport after HTO. Continued preoperative sports participation was associated with a successful RTS. Future studies need to identify additional prognostic factors.

Response rate and costs for automated patient-reported outcomes collection alone compared to combined automated and manual collection.

BACKGROUND: The response rate on patient-reported outcome measurements (PROMs) necessary to adequately evaluate a treatment and improve patient care is unknown. Hospitals generally aim for the highest possible response rate without insight into the increase in costs involved. This study aimed to investigate which PROMs response rate is achievable in relation to the costs in an orthopaedic practice. METHODS: In an observational study, patients planned for orthopaedic surgery were asked to participate per surgical procedure (5769 surgical procedures at 5300 patients). Patient-reported outcomes (PROs) collection with a digital online automated PROMs collection system (minimal effort) was compared to a combined automated system and manual collection (maximal effort). Response rate was calculated preoperative and at two postoperative time points separately, and on all three time points together. Costs were calculated for the study period, per year and per surgical procedure. Calculations were executed for all surgical procedures and for three subgroups: knee arthroplasty, hip arthroplasty and anterior cruciate ligament reconstruction (ACLR). RESULTS: Using maximal effort the response rate increased for all surgical procedures compared to minimal effort; the preoperative response rate from 86% to 100% and the postoperative response rates from 55% to 83% (3 or 6 months) and 53% to 83% (12 months). Concerning the response at all three time points for all surgical procedures, minimal effort resulted in 44% response rate and increased to 76% with maximal effort. Lowest postoperative response rates were found in the ACLR group for both maximal and minimal effort. A costs difference of €5.55-€5.98 per surgical procedure between maximal and minimal effort was found. CONCLUSIONS: A two times higher PROMs response rate for patients responding at all three time points (44% versus 76%) is achievable with maximal effort compared to the use of an automated PROMs collection system only. Manual collection adds a cost of €5.5-€6 per surgical procedure to automated PROMs collection alone. It is debatable if these additional costs are justifiable from a value-based health care perspective as the response rate for adequate evaluation of a treatment is still unknown.

Eight respectively nine out of ten patients return to sport and work after distal femoral osteotomy.

PURPOSE: Distal femoral osteotomy (DFO) is a well-accepted procedure for the treatment of femoral deformities and associated symptoms including osteoarthritis, especially in younger and physically active patients in whom knee arthroplasty is undesirable. Still, there is an apparent need for evidence on relevant patient outcomes, including return to sport (RTS) and work (RTW), to further justify the use of knee osteotomy instead of surgical alternatives. Therefore, the purpose of the present study was to investigate the extent and timing of patients' RTS and RTW after DFO. METHODS: This monocentre, retrospective cohort study included consecutive DFO patients, operated between 2012 and 2015. Out of 126 eligible patients (18-70 years, 63% female), all patients responded, and 100 patients completed the questionnaire. Median follow-up was 3.4 years (range 1.5-5.2). The predominant indication for surgery was symptomatic unicompartmental osteoarthritis and valgus or varus leg alignment caused by a femoral deformity. The primary outcome measure was the percentage of RTS and RTW. Secondary outcome measures included time to RTS/RTW, sports level and frequency, the median pre-symptomatic and postoperative Tegner activity score (1-10, higher is more active) and the postoperative Lysholm score (0-100, higher is better). RESULTS: Out of 84 patients participating in sports preoperatively, 65 patients (77%) returned to sport postoperatively. Forty-six patients (71%) returned to sports within 6 months. Postoperative participation in high-impact sports was possible though less frequent compared to preoperative participation. Out of 80 patients working preoperatively, 73 (91%) returned to work postoperatively, of whom 59 patients (77%) returned within 6 months. The median pre-symptomatic Tegner activity score [4.0 (range 0-10)] was significantly higher (p < 0.01) than the reported Tegner score at follow-up [3.0 (range 0-10)]. The mean Lysholm score at follow-up was 68 (± 22). No significant differences were found between the osteoarthritis- and non-osteoarthritis group. CONCLUSION: Eight out of ten patients return to sport and nine out of ten patients return to work after DFO. These are clinically relevant findings, because they further justify DFO as a surgical alternative to KA in young, active knee OA patients who wish to return to high activity levels. LEVEL OF EVIDENCE: Retrospective cohort study, Level III.

Predictors of Return to Work After High Tibial Osteotomy: The Importance of Being a Breadwinner.

BACKGROUND: Limited evidence exists on patient-relevant outcomes after high tibial osteotomy (HTO), including return to work (RTW). Furthermore, prognostic factors for RTW have never been described. PURPOSE: To investigate the extent and timing of RTW in the largest HTO cohort investigated for RTW to date and to identify prognostic factors for RTW after HTO. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Consecutive patients who underwent HTO between 2012 and 2015 were included. Patients received a questionnaire at a mean follow-up of 3.6 years. Questions were asked pre- and postoperatively regarding work status, job title, working hours, preoperative sick leave, employment status, and whether patients were their family's breadwinner. The validated Work Rehabilitation Questionnaire (WORQ) was used to assess difficulty with knee-demanding activities. Prognostic factors for RTW were analyzed using a logistic regression model. Covariates were selected based on univariate analysis and a directed acyclic graph. RESULTS: We identified 402 consecutive patients who underwent HTO, of whom 349 were included. Preoperatively, 299 patients worked, of whom 284 (95%) achieved RTW and 255 (90%) returned within 6 months. Patients reported significant postoperative improvements in performing knee-demanding activities. Being the family's breadwinner was the strongest predictor of RTW (odds ratio [OR], 2.92; 95% confidence interval [CI], 1.27-6.69). In contrast, preoperative sick leave was associated with lower odds of RTW (OR, 0.20; 95% CI, 0.08-0.46). CONCLUSION: After HTO, 95% of patients were able to RTW, of whom 9 of 10 returned within 6 months. Breadwinners were more likely to RTW, and patients with preoperative sick leave were less likely to RTW within 6 months. These findings may be used to improve preoperative counseling and expectation management and thereby enhance work-related outcomes after HTO.

Medial open wedge high tibial osteotomy: can delayed or nonunion be predicted?

BACKGROUND: The opening wedge approach to high tibial osteotomy (HTO) is perceived to have some advantages relative to the closing wedge approach but it may be associated with delayed and nonunions. Because nonunions evolve over months, it would be advantageous to be able to identify risk factors for and early predictors of nonunion after medial opening wedge HTO. QUESTIONS/PURPOSES: We sought to determine whether (1) preoperatively identifiable patient factors, including tobacco use, body mass index > 30 kg/m(2), and degree of correction, are associated with nonunion, and (2) a modified Radiographic Union Score for Tibial Fractures (RUST) score, taken at 6 weeks and 3 months, would be predictive for delayed or nonunion after medial opening wedge HTO. METHODS: The medical records and radiographs of 185 patients, 21 bilateral cases, treated with a medial open wedge HTO using the TomoFix(®) device were retrospectively evaluated. For all patients, demographic data regarding risk factors were collected from their records. Diagnosis for delayed or nonunion was already done earlier for standard medical care by the orthopaedic surgeon based on clinical and radiographic grounds. For the retrospective radiographic evaluation, a modified RUST score was used in which each tibial cortex is scored by one observer. Logistic regression analysis was used to identify preoperative and postoperative predictive factors for developing delayed or nonunion. In the series, a total of 19 patients (9.2%) developed clinically delayed/nonunion of whom 10 patients (4.9%) developed a nonunion. RESULTS: Smoking was identified as a risk factor for developing delayed/nonunion (19% for smokers versus 5.4% for nonsmokers; p = 0.005; odds ratio, 4.1; 95% confidence interval, 1.5-10.7). By contrast, body mass index, lateral cortical hinge fracture, age, infection, and degree of correction were not risk factors. Patients with delayed/nonunion had lower RUST scores at all time points when a radiograph was taken compared with the total study group. CONCLUSIONS: The RUST score at 6 weeks and 3 months after surgery and the use of tobacco were identified as predictive factors for development of delayed union and nonunion after open wedge HTO. Based on these results, we now actively try to stop patients from smoking and these data are helpful in doing that. The RUST score may be of use to identify which patients are at risk for developing a delayed union so that interventions may be offered earlier in the course of care. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Biomechanical testing of distal femur osteotomy plate fixation techniques: the role of simulated physiological loading.

BACKGROUND: Implants for fracture and/or osteotomy fixation are often tested according to basic mechanical test models such as open gap tests or 4-point-bending tests. These may be suitable to test and compare different implants for safety and clinical approval, but are not always representative of the post-operative situation, which is decisive when it comes to bone healing. In the current study the Knee Expert Group of the Association for the Study of Internal Fixation has compared the available open gap test results of the latest version of the TomoFix Medial Distal Femoral Plate and the antecedent plate design, with the test results of a more physiological and life-like test model. In the open gap test model the antecedent plate design was found to have superior stiffness and fatigue strength. METHODS: In the current study simulated postoperative conditions for medial closing wedge supracondylar osteotomies were used. The constructs were subjected to cyclical axial and torsional loading and were subsequently tested to failure. RESULTS: The more life-like tests in this study showed that the latest version was either more or equally stable and stiff than the antecedent version of the plate, in all of the tests. It is argued that the difference in results between the two loading models is due to differences in test design. CONCLUSIONS: These test results stress the importance of not only using standard open gap and 4-point-bending tests, but also to use as life-like as possible test conditions for any form of biomechanical testing of new implants.

An unusual way of intramedullar fixation after a periprosthetic supracondylar femur fracture.

Periprosthetic supracondylar femoral fractures after a total knee arthroplasty are difficult surgical problems. We report a case of an 84-year-old woman with an osteoporotic fracture that was not deemed amenable to conventional treatment. In this case, a complete consolidation was achieved by using a proximal femur nail antirotation nail upside down and through the fracture for fixation.

Reconstructive osteotomy of fibular malunion: review of the literature.

The treatment of ankle fractures has a primary goal of restoring the full function of the injured extremity. Malunion of the fibula is the most common and most difficult ankle malunion to reconstruct. The most frequent malunions of the fibula are shortening and malrotation resulting in widening of the ankle mortise and talar instability, which may lead to posttraumatic osteoarthritis. The objective of this article is to review the literature concerning the results of osteotomies for correcting fibular malunions and to formulate recommendations for clinical practice. Based on available literature, corrective osteotomies for fibular malunion have good or excellent results in more than 75% of the patients. Reconstructive fibular osteotomy has been recommended to avoid or postpone sequela of posttraumatic degeneration, an ankle arthrodesis or supramalleolar osteotomy. The development of degenerative changes is not fully predictable; therefore, it is advisable to reconstruct a fibular malunion soon after the diagnosis is made and in presence of a good ankle function. Recommendations were made for future research because of the low level of evidence of available literature on reconstructive osteotomies of fibular malunions.

Early full weight bearing is safe in open-wedge high tibial osteotomy.

BACKGROUND AND PURPOSE: In open-wedge, valgus osteotomy of the upper tibia, there are concerns regarding the initial stability and ability to retain the correction. Rehabilitation protocols vary depending on the osteotomy technique and the fixation method. Angle-stable implants offer superior initial stability. Early full weight bearing appears to be possible using these implants. In this prospective cohort study, we measured migration in open-wedge osteotomy in patients following an early full weight bearing protocol and compared the results to those from a historical cohort of open-wedge osteotomy patients who followed a standard protocol (full weight bearing after 6 weeks) using radiostereometry. METHODS: 14 open-wedge osteotomies fixated with the angle-stable Tomofix implant were performed; patients were allowed full weight bearing as soon as pain and wound healing permitted. Radiostereometry was used to measure motion across the osteotomy at regular intervals. Improvement in pain and functional outcome were assessed postoperatively. The results were compared to those from a group of 23 patients who had undergone the same operation but had used a standard rehabilitation protocol. RESULTS: There were no adverse effects because of the early full weight bearing protocol. There were no differences in motion at the osteotomy between groups as measured by radiostereometry. In both groups, pain and function improved substantially without any differences between groups. Patients in the early weight bearing group achieved the same result but in a shorter time. INTERPRETATION: Tomofix-plate-fixated open-wedge high tibial osteotomy allows early full weight bearing without loss of correction.

Valgus bracing in patients with medial compartment osteoarthritis of the knee. A gait analysis study of a new brace.

A new valgus brace was evaluated in 15 patients with medial osteoarthritis of the knee and a varus leg axis. Significant improvement of pain and function were found after 6 weeks of brace treatment. Gait analysis showed that the brace had a tendency of lowering the peak varus moment about the knee. This effect was more profound in the presence of higher initial varus deformity angle of the knee. Furthermore, bracing led to a small decrease of knee extension at the end of the swing phase and an increase of walking velocity. The mechanisms identified by gait analysis in this study may be of clinical importance for future developments in brace treatment.

Mechanism of bone incorporation of beta-TCP bone substitute in open wedge tibial osteotomy in patients.

A histological study was performed of bone biopsies from 16 patients (17 biopsies) treated with open wedge high tibial osteotomies for medial knee osteoarthritis. The open wedge osteotomies were filled with a wedge of osteoconductive beta tricalcium phosphate (beta-TCP) ceramic bone replacement. At the time of removal of the fixation material, core biopsies of the area where the beta-TCP was located were taken at different follow-up periods (6-25 months). beta-TCP resorption, bone ingrowth and bone remodelling were studied. We hypothesized that the incorporation and remodelling process occurs similarly as in animals. Histology showed a good resorption of the beta-TCP with complete incorporation and remodelling into new bone. The different phases as described in animal studies were found. A correlation was found between histological findings and radiological assessment. In conclusion, beta-TCP appeared to be a bone replacement material with optimal biocompatibility, resorption characteristics and bone conduction properties for the clinical use.

Tricalcium phosphate granules or rigid wedge preforms in open wedge high tibial osteotomy: a radiological study with a new evaluation system.

The capacity of two forms of porous beta-tricalcium phosphate bone substitutes (TCP) to promote bone healing in open wedge high tibial osteotomy (OWHTO) was studied. We reviewed the X-rays of 27 osteotomies, with either TCP wedges or TCP granules as filling material, to compare the bone healing rates and bone remodelling, at specific postoperative intervals. A new radiologic rating system for OWHTO was created and tested for clinical applicability. All osteotomies healed uneventfully and complete resorption of TCP was demonstrated at 1 year postoperative in 85% (n = 23) of the procedures. In 44% (n = 10) of these 23 procedures, the osteotomy site was no longer visible. No difference in bone healing rate and bone remodelling was found when comparing the use of granules to a wedge, and no adverse effects of TCP were observed. The good inter- (k = 0.7) and intraobserver (k = 0.6) reliability of the new radiologic rating system enables clinical use. Good bone healing was found in OWHTO with both wedges and granules of TCP.