Litigation in orthopedic surgery: What can we do to prevent it? Systematic analysis of 126 legal actions involving four university hospitals in France.

INTRODUCTION: Orthopedic surgery produces 20% of medical malpractice claims. However only a few studies have examined the reasons for and consequences of these disputes, and they have usually been limited to a single hospital. This led us to perform a retrospective analysis of the claims at four teaching hospitals in northwestern France. The goals were (1) to describe the circumstances that led to these claims and recommend ways to prevent them, and (2) to describe the conduct of the proceedings and their financial and social outcomes. HYPOTHESIS: A systematic analysis of litigation cases will provide accurate information on the circumstances leading to these claims. METHODS: The study included 126 disputes settled between 2000 and 2010 and related to orthopedic or trauma care given at one of four teaching hospitals in northwestern France. The method of recourse, grounds of the complaint, type of surgical procedure, expert findings and amount of the award were systematically analyzed. RESULTS: Of these 126 cases, 54 (43%) of them were submitted to the French CRCI (regional conciliation and compensation commission), 48 (39%) to the French administrative courts and 51 (41%) were settled amicably. Multiple methods of recourse were used in 21% of cases (n=27/126). The average length of administrative court proceedings was 36.7±27 months [4-102], which was significantly longer than the CRCI proceedings (22.7±17.9 months [3-80]) or out-of-court settlement (23.7±21.5 months [0-52]) (p<0.0001). Damages were sought for medical error or treatment-related risk in 67.5% of the complaints (n=85/126), and for failure to inform in 15.8% of cases (n=20/126). There was a suspected surgical site infection in 79.3% of cases (n=100/126). There were multiple grounds for complaint in 68.3% of cases (n=86/126). Poor communication between the physician and patient was identified in 26.2% of cases (n=33/126). Damages were awarded in 25% of cases (n=31/126), with an average award of €58,303±€91,601 [0-357,970]. CONCLUSION: The primary grounds for legal action are infection-related complications combined with a deterioration in the doctor-patient relationship. Disputes could be prevented by continuing efforts to combat hospital-acquired infections and providing better communications training. LEVEL OF PROOF: IV (retrospective study).

Short-term complications in intra- and extra-articular anterior cruciate ligament reconstruction. Comparison with the literature on isolated intra-articular reconstruction. A multicenter study by the French Arthroscopy Society.

INTRODUCTION: Lateral tenodesis (LT) is performed to limit the risk of iterative tear following anterior cruciate ligament (ACL) reconstruction in at-risk patients. By adding an extra procedure to isolated ACL graft, LT reconstruction increases operating time and may complicate postoperative course. The objective of the present study was to evaluate the rate of early complications. The study hypothesis was that associating ALL reconstruction to ACL reconstruction does not increase the complications rate found with isolated ACL reconstruction. MATERIAL AND METHODS: A prospective multicenter study included 392 patients: 70% male; mean age, 29.9 years; treated by associated ACL and LT reconstruction. All adverse events were inventoried. RESULTS: Mean hospital stay was 2 days, with 46% day-surgery. Walking was resumed at a mean 27 days, with an advantage for patients treated by the hamstring technique. The early postoperative complications rate was 12%, with 1.7% specifically implicating LT reconstruction: pain, hematoma, stiffness in flexion and extension, and infection. There was a 5% rate of surgical revision during the first year, predominantly comprising arthrolysis for extension deficit. The 1-year recurrence rate was 2.8%. DISCUSSION: The complications rate for combined intra- and extra-articular reconstruction was no higher than for isolated intra-articular ACL reconstruction, with no increase in infection or stiffness rates. The rate of complications specific to ALL reconstruction was low, at 1.7%, and mainly involved fixation error causing lateral soft-tissue impingement. LEVEL OF EVIDENCE: IV, prospective multicenter study.

Midterm results of combined intra- and extra-articular ACL reconstruction compared to historical ACL reconstruction data. Multicenter study of the French Arthroscopy Society.

INTRODUCTION: During anterior cruciate ligament (ACL) reconstruction procedures, anterolateral reconstruction (ALR) can also be performed to improve the knee's rotational stability. However, the effectiveness of this supplemental technique and its impact on the risk of retears and on the onset of secondary degenerative changesare controversial. HYPOTHESIS: ALR improves control over the pivot shift, reduces the retear risk and delays the appearance of secondary degenerative lesions. MATERIAL AND METHODS: Clinical examination, knee laxity measurements and X-ray evaluations were done in 478 patients with more than 3years' follow-up after combined ACL and ALR from 11 participating hospitals. The mean patient age at the time of surgery was 28years. Eighty-eight percent of the patients participated in pivot sports and 45% were competitive athletes. The findings of this study were compared to historical isolated ACL reconstruction data. RESULTS: The average follow-up was 6.8years. No detectable pivot shift was found in 83% of patients, while 12.8% of patient had a smooth glide. The side-to-side difference in anteroposterior knee laxity with maximum manual force was less than 3mm in 66% of patients and less than 5mm in 95%. The retear rate was 5.4%, with half of these patients undergoing revision ACL surgery. Secondary meniscus damage requiring surgery occurred in 6.3% of patients; the radiological osteoarthritis rate was 17.5%. DISCUSSION: When compared to historical ACL reconstruction data, combined intra- and extra-articular reconstruction does not increase the complication rate. At a mean follow-up of 6.8years, it provides better control over the pivot shift along with a low retear rate and low occurrence of secondary meniscus injuries. LEVEL OF EVIDENCE: IV, multicenter study.

Combined intra- and extra-articular grafting for revision ACL reconstruction: A multicentre study by the French Arthroscopy Society (SFA).

BACKGROUND: A careful analysis of the reasons for ACL reconstruction failure is essential to selection of the optimal surgical revision technique designed to ensure good rotational stability and to minimise the risk of re-rupture. OBJECTIVE: To evaluate anterolateral ligament (ALL) stabilisation during revision ACL reconstruction. HYPOTHESIS: ALL stabilisation during revision ACL reconstruction provides good rotational stability without increasing the risk of complications. MATERIAL AND METHODS: This multicentre study included 349 patients, 151 retrospectively and 198 prospectively. There were 283 males and 66 females. Inclusion criteria were an indication for revision ACL reconstruction surgery with combined intra-articular reconstruction and ALL stabilisation after failed autograft ACL reconstruction, and intact PCL. Exclusion criteria were primary ACL reconstruction and concomitant peripheral medial and/or lateral lesions. Each patient underwent a clinical and radiographic evaluation before and after revision surgery. Before revision surgery, the mean IKDC score was 56.5±15.5 and 96% of patients were IKDC C or D. RESULTS: Rates were 5.0% for early and 10.5% for late postoperative complications. Lachmann's test had a hard stop at last follow-up in 97% of patients. The pivot-shift test was positive in 1% of patients. The mean subjective IKDC score was 84.5±13.0 and 86.5% of patients were IKDC A or B. The proportions of patients with radiographic knee osteoarthritis at last follow-up was unchanged for the lateral tibio-femoral and patello-femoral compartments but increased by 9.7% to 21.2% for the medial tibio-femoral compartment. The re-rupture rate was 1.2% and the further surgical revision rate was 5.4%. CONCLUSION: Anterior laxity at last follow-up was consistent with previous studies of revision ACL reconstruction. However, rotational stability and the re-rupture risk were improved. ALL stabilisation is among the techniques that deserve consideration as part of the therapeutic options for revision ACL reconstruction. LEVEL OF EVIDENCE: IV, retrospective and prospective cohort study.

Is coracoclavicular stabilisation alone sufficient for the endoscopic treatment of severe acromioclavicular joint dislocation (Rockwood types III, IV, and V)?

BACKGROUND: The primary objective was to evaluate correlations linking anatomical to functional outcomes after endoscopically assisted repair of acute acromioclavicular joint dislocation (ACJD). HYPOTHESIS: Combined acromioclavicular and coracoclavicular stabilisation improves radiological outcomes compared to coracoclavicular stabilisation alone. MATERIAL AND METHODS: A prospective multicentre study was performed. Clinical outcome measures were pain intensity on a visual analogue scale (VAS), subjective functional impairment (QuickDASH score), and Constant's score. Anatomical outcomes were assessed on standard radiographs (anteroposterior view of the acromioclavicular girdle and bilateral axillary views) obtained preoperatively and postoperatively and on postoperative dynamic radiographs taken as described by Tauber et al. RESULTS: Of 116 patients with acute ACJD included in the study, 48% had type III, 30% type IV, and 22% type V ACJD according to the Rockwood classification. Coracoclavicular stabilisation was achieved using a double endobutton in 93% of patients, and concomitant acromioclavicular stabilisation was performed in 50% of patients. The objective functional outcome was good, with an unweighted Constant's score ≥ 85/100 and a subjective QuickDASH functional disability score ≤ 10 in 75% of patients. The radiographic analysis showed significant improvements from the preoperative to the 1-year postoperative values in the vertical plane (decrease in the coracoclavicular ratio from 214 to 128%, p=10(-6)) and in the horizontal plane (decrease in posterior displacement from 4 to 0mm, p=5×10(-5)). The anatomical outcome correlated significantly with the functional outcome (absolute R value=0.19 and p=0.045). We found no statistically significant differences across the various types of constructs used. Intra-operative control of the acromioclavicular joint did not improve the result. Implantation of a biological graft significantly improved both the anatomical outcome in the vertical plane (p=0.04) and acromioclavicular stabilisation in the horizontal plane (p=0.02). The coracoclavicular ratio on the anteroposterior radiograph was adversely affected by a longer time from injury to surgery (p=0.02) and by a higher body mass index (BMI) (p=0.006). High BMI also had a negative effect on the difference in the distance separating the anterior edge of the acromion from the anterior edge of the clavicle between the injured and uninjured sides, as assessed on the axillary views (p=0.009). CONCLUSION: This study demonstrates that acute ACJD requires stabilisation in both planes, i.e., at the coracoclavicular junction and at the acromioclavicular joint. Coracoclavicular stabilisation alone is not sufficient, regardless of the type of implant used. Implantation of a biological graft should be considered when the time from injury to surgery is longer than 10days. The weight of the upper limb should be taken into account, with 6weeks of immobilisation to unload the construct in patients who have high BMI values. LEVEL OF EVIDENCE: II, prospective non-randomised comparative study.

Prognostic factors to succeed in surgical treatment of chronic acromioclavicular dislocations.

INTRODUCTION: Treatment of chronic acromioclavicular joint dislocation (ACJD) remains a poorly known and controversial subject. Given the many surgical options, it is not always easy to determine which steps are indispensable. METHODS: This article reports a multicenter prospective study. The clinical and radiological follow-up involved a comparative analysis of the preoperative and postoperative data at 1 year, including pain (visual analogue scale), subjective functional incapacity (QuickDASH), and the objective Constant score, as well as a comparative analysis of vertical and horizontal movements measured on simple x-rays. RESULTS: Based on a series of 140 operated ACJDs, we included 24 chronic ACJDs. The mean time to surgery was 46 weeks (range, 1 month to 4 years). The patients' mean age was 41 years, with a majority of males (75%), 72% of whom participated in recreational sports. Professionally, 40% of the subjects had jobs involving manual labor. We noted 40% grade III, 24% grade IV, and 36% grade V injury according to the Rockwood classification. In 92% of cases, coracoclavicular stabilization was provided by a double button implant, reinforced with a biological graft in 88% of the cases. In 29%, millimeters to centimeters of the distal clavicle were resected and acromioclavicular stabilization was associated in 54%. We observed complications in 33% of the cases. At 1 year postoperative, 21 patients underwent clinical and radiological follow-up (87.5%). Only 35% of the patients were satisfied or very satisfied, whereas 100% of them would recommend the operation. Full-time work was resumed in 91% of the cases and all sports could be resumed in 86%. The pre- and postoperative values at 1 year changed as follows: the mean Constant score improved from 61 to 87 (p=0.00002); the subjective QuickDASH score decreased from 41 to 9 (p=0.00002); and radiologically significant reduction of the initial displacement was observed in the vertical plane (p<10(-3)) and the horizontal plane (p=0.022). CONCLUSION: In this study, the favorable prognostic factors found were: time to surgery less than 3 months (p=0.02), associated acromioclavicular stabilization, and postoperative immobilization with a sling extended to 6 weeks. However, resection of the distal clavicle did not influence the final result. LEVEL OF PROOF: Level II prospective non-randomized comparative study.

Minimally invasive posterior approach in the popliteal fossa for semitendinosus and gracilis tendon harvesting: an anatomic study.

INTRODUCTION: Harvesting the semitendinosus (ST) and gracilis (GR) tendons at the anteromedial side of the knee may be hampered by a conjoint tendon insertion on the tibial metaphysis and an accessory bundle between the ST and the medial gastrocnemius. Locating and sparing the terminal branches of the saphenous nerve are difficult on an anteromedial approach. The principal objective of the present anatomic study was to assess the feasibility of ST and GR harvesting from a minimally invasive posterior approach in the popliteal fossa. The secondary objective was to analyze the risk of saphenous nerve branch lesion during harvesting. METHOD: Ten cadaver knees, free of scarring, were used. The whole body was positioned supine. The tendons were located in the popliteal fossa with the knee in 30° flexion. A mini-incision was performed in the fossa. The ST and GR tendons were located, and retrograde followed by anterograde stripping was performed. Tendon lengths and diameters were measured. The knees were then dissected to check for saphenous nerve branch lesions (anterior, infrapatellar and posterior branches). RESULTS: The GR and ST tendons were respectively located at 14.4 and 24 mm from the medial edge of the knee. In 90% of cases, there was an accessory ST bundle toward the medial gastrocnemius muscle, 26 mm below the posterior edge. Tendons could be harvested without deviation of the stripper. Knee dissection did not find any saphenous nerve branches, these being protected by the sartorius fascia. DISCUSSION: Posterior ST and GR tendon harvesting in the popliteal fossa is reliable and reproducible. It allows easy sectioning of the accessory ST bundle, without deviation during retrograde stripping. Unlike anterior harvesting, which leads to a rate of saphenous branch lesion of 50-78%, posterior harvesting protects the nerve branches by keeping away from the sartorius. LEVEL OF EVIDENCE: Level 4.

Sacro-iliac joint arthroscopy for arthrodesis after traumatic dislocation. Cadaver and clinical feasibility study.

BACKGROUND: Sacro-iliac arthrodesis usually requires an extended posterior approach, which is associated with a number of dreaded complications. Here, we assessed the feasibility of arthroscopic exploration of the dislocated sacro-iliac joint. MATERIALS AND METHODS: In the first step of our study, we used ligament section to induce loss of sacro-iliac joint coaptation in a cadaver. We then studied 5 patients with Tile C pelvic ring injuries. Arthroscopy was used to clear the joint of fibrous tissue and to roughen the bone to subchondral level in order to induce sacro-iliac arthrodesis. In addition, posterior fixation was performed using a hinge system or an ilio-sacral screw. RESULTS: The cadaver study confirmed the feasibility of sacro-iliac arthroscopy after disruption of the strong posterior inter-osseous ligament. In the clinical part of the study in 5 patients with Tile C pelvic ring injuries, arthroscopy allowed direct visualisation extending to the anterior part of the joint space. A power burr and synovial knife were introduced to remove the interposed fibrous tissue and to roughen the bone to subchondral level in order to induce joint fusion. In addition, percutaneous or open posterior fixation was performed in all 5 patients. No infectious complications were recorded. DISCUSSION: An arthroscope cannot be introduced into the normal sacro-iliac joint. In contrast, after traumatic sacro-iliac dislocation, arthroscopy can be used to evaluate the intra-articular injuries and to roughen the bone to subchondral level.

Anterior knee laxity measurement: comparison of passive stress radiographs Telos(®) and "Lerat", and GNRB(®) arthrometer.

INTRODUCTION: In patients with anterior cruciate ligament (ACL) tears, anterior laxity can be measured using stress radiographs or more recently introduced electronic measurement devices. HYPOTHESIS: The GNRB(®) arthrometer offers a radiation-free method of measuring anterior knee laxity whose diagnostic value is identical to that of Telos(®) or Lerat stress radiographs. PATIENTS AND METHODS: One hundred and fifty-seven patients (40 years [18-69]) scheduled for knee arthroscopy were evaluated using the GNRB(®) and two series of stress radiographs of both knees, one obtained using a 250-N Telos(®) device and the other using the technique described by Lerat (posterior translation of the femur/tibia under a 9-kg loading device). Arthroscopic evaluation of the ACL served as the reference standard for assessing the diagnostic performance of the radiological and instrumental laxity measurements. RESULTS: Under arthroscopic examination, the ACL was normal in 50.3%; "healed to roof of the notch" (partial tear) in 9.6%, "posterolateral bundle preserved" (partial tear) in 7.0%, "healed to the posterior cruciate ligament" (PCL) in 17.8%, and "empty notch" (complete tear) in 15.3%. In partial ACL tears, no significant differences in anterior laxity were found across the three measurement techniques. Telos(®) and GNRB(®) laxities were greater in the complete-tear group than in the normal-ACL, partial-tear, and healed-to-PCL groups. With the Lerat technique, the only significant differences were between the complete-tear group and the normal-ACL and partial-tear groups. Telos(®) and GNRB(®) showed similar diagnostic performance (sensitivity>62%, specificity>75%), whereas the Lerat technique lacked sensitivity (sensitivity=43.2%, specificity=82.7%) at 3mm. DISCUSSION: Diagnostic performance was lower in our study than in earlier reports. The GNRB(®) performed as well as Telos(®). The non-irradiating nature of GNRB(®) assessments allows repeated measurements for therapeutic or diagnostic purposes. LEVEL OF EVIDENCE: Level III, prospective case-control study.

Arthroscopic repair of large and massive rotator cuff tears using the side-to-side suture technique. Mid-term clinical and anatomic evaluation.

UNLABELLED: PREAMBLE: Arthroscopic repair is our treatment of choice for massive rotator cuff tears. In order to reduce tension, we perform a side-to-side suture technique. The purpose of our work was to study the outcome of such technique by evaluating functional score and rotator cuff integrity using ultrasound at 2-year follow-up. HYPOTHESIS: The "side-to-side" arthroscopic repair of large and massive rotator cuff tears provides a long-term continuity of rotator cuff mechanism, enhances function and relieves pain with low morbidity. TYPE OF STUDY: Retrospective monocenter study. MATERIAL AND METHODS: We included a continuous series of 50 patients of mean age 66.6 years (46-80), operated on between January 2007 and March 2008 for full-thickness retracted tears of the supraspinatus extending or not to the infraspinatus tendon. Management consisted of arthroscopic subacromial bursectomy, acromioplasty and side-to-side repair of the rotator cuff tendons with secure anchor fixation to the tuberosity. The relative Constant score was used for clinical evaluation preoperatively and at a minimum of 24 months after surgery. The continuity of rotator cuff mechanism was evaluated using ultrasound. RESULTS: The mean relative Constant score improved significantly (p<0.05) from 40% (18-67) preoperatively to 91.7% (40-107) postoperatively. Fifty-six percent of the rotator cuffs from this series demonstrated continuity with a postoperative relative Constant score of 98.4% (74-121) and an increase in the shoulder strength score of 3.6 kg (1-6). Forty-four percent of the rotator cuffs had recurrent tear with an overall relative Constant score of 83.6% (4-126) and we did not observe any improvement in the strength score in this sub-group. Eighty-eight percent of the patients were satisfied or very satisfied with their outcome. DISCUSSION: At a minimum 24-month follow-up, the side-to-side suturing technique reported excellent functional results with a very high satisfaction rate. For these large and massive rotator cuff tears sometimes considered as irreparable, ultrasound confirmed the continuity of the repair in 56% of the cases. Unhealed patients were not disadvantaged since they experienced pain relief and functional improvement. However, in this sub-group of patients, recovery of shoulder strength was poor. LEVEL OF EVIDENCE: Level IV.

Open and subcutaneous recent tibialis anterior tendon ruptures: does postoperative immobilization method influence outcome?

UNLABELLED: We report on seven traumatic lesions of the tibialis anterior tendon (one subcutaneous rupture and six open tears) in seven injured patients of mean age 45 years [17-79] all managed by direct suture and immobilization either using a cast boot (four cases) or a lower leg external fixator (three cases). After a mean follow-up of 31 months (6-50), external fixation achieved favourable clinical results with no specific complication. External fixation improves the conditions for suture efficiency, provides full immobilization and facilitates wound care in patients at a high risk of developing cutaneous complications. In accordance with data published in the literature, immobilization by means of a windowed cast boot achieved satisfactory results in patients with no risk factors. This method compatible with early mobilization avoids placement of a posterior splint which could induce slackening and weakening of tendon repair. LEVEL OF EVIDENCE: Retrospective study (Level IV).

Laxity measurements using stress radiography to assess anterior cruciate ligament tears.

INTRODUCTION: The clinical diagnosis of the anterior cruciate ligament (ACL) tear is based on demonstrating anterior subluxation of the tibia on the femur. In any of the following perspectives, diagnostic (cutoff value confirming rupture), prognostic (treatment efficacy), and therapeutic (laxity influencing the treatment), this laxity can be measured on stress X-rays. WORKING HYPOTHESIS: The diagnostic value of dynamic radiographs is low for ACL rupture. Passive Telos(®) X-rays have better diagnostic value, better radiologic quality, and are easier to carry out than active Franklin-type X-rays. MATERIAL AND METHODS: A cohort of 112 patients (28 females, 84 males; mean age, 33.7 years [range, 18-72 years]) with an indication for knee arthroscopy were studied prospectively. Before undergoing the arthroscopic treatment, two series of images of both knees were taken: one series of passive anterior drawer dynamic X-rays on a Telos(®) device at 250 N and a series of active anterior drawer dynamic X-rays according to Franklin (contraction of the quadriceps against 7 kg of weight at the ankle). The arthroscopic evaluation of the ACL (reference status) was compared to the anterior laxity measurements (absolute and differential) of each knee compartment (medial, lateral, and average) to determine the diagnostic value of the two radiological tests. RESULTS: We found 70 patients with an "arthroscopically ruptured ACL", 32 with an "arthroscopically healthy ACL", and 10 with a "partial rupture". The measurement of the anterior drawer values on the dynamic X-rays (active and passive) by two independent observers was reliable and reproducible (ICC>0.80), particularly when using the medial compartment (ICC=0.96) and the differential values eliminating the interobserver measurement error and interindividual laxity variations. In terms of X-ray technique, the active images were more frequently painful and the radiographic result showed less good quality than the Telos images. The anterior drawer values in the "healthy ACL" group were significantly less than in the "ruptured ACL" group for the Telos(®) images, whether the measurements were absolute or differential. For the Franklin images, this difference was only significant for the absolute values. Used for diagnosis (4-mm differential on the medial compartment), the passive dynamic images had lower diagnostic values (Se=59% and Sp=90%) than the series reported in the literature, which were marked by great heterogeneity. CONCLUSION: The measurement of anterior drawer values on Telos(®) and Franklin dynamic X-rays is a reliable and reproducible measurement, particularly when using the medial compartment and differential measurements. This small series did not demonstrate a diagnostic value for the Franklin images, contrary to the Telos(®) X-rays. Used for diagnostic purposes, the Telos(®) images had a low sensitivity; consequently, they should be used preferentially for prognostic or therapeutic purposes. LEVEL OF EVIDENCE: Level III, prospective case-control study.