Tag Archive | Anterior cruciate ligament

FDA OKs Synthetic Implant for Repairing ACL Tears

OrthoBuzz has been following the development of the Bridge-Enhanced ACL Repair (BEAR) implant—a synthetic alternative to graft-based anterior cruciate ligament reconstruction—since 2015 (see previous OrthoBuzz posts). On December 16, 2020 the FDA granted authorization to Miach Orthopaedics, Inc. to market the implant.

The BEAR implant is made from bovine collagen. After securing it with sutures to the torn ends of a completely ruptured ACL, the surgeon injects the patient’s own blood into the implant, which forms a clot that enhances ligament healing. Within 8 weeks, the implant is resorbed and replaced by the body’s own tissue.

The FDA’s authorization was based on results from a 100-patient randomized clinical trial, in which 65 patients received the BEAR implant and 35 underwent conventional autograft reconstruction. After 2 years, patient-reported outcomes in both groups were similar for pain, knee function, and sports activity, and arthrometry showed nearly identical joint-laxity outcomes. It remains to be seen how durable the BEAR implant will be over time and how much arthritis will develop in BEAR-treated knees 15 or 20 years from now.

The FDA’s marketing authorization for the BEAR implant was granted under the agency’s de novo device review pathway. That means that subsequent similar devices can be reviewed through the FDA’s 510(k) process, which requires a demonstration of “substantial equivalence” to the predicate device.

What’s New in Orthopaedic Rehabilitation 2020

Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all such OrthoBuzz specialty-update summaries.

This month, co-author Nitin B. Jain, MD selected the most clinically compelling findings from the >30 studies summarized in the November 18, 2020 “What’s New in Orthopaedic Rehabilitation.”

Hip Fracture
–A retrospective cohort study of >43,000 patients with hip fracture and dementia1 found that more frequent, earlier, and larger amounts of postoperative, in-hospital rehabilitation were associated with better recovery in activities of daily living after discharge.

Rotator Cuff
–A cohort study used propensity-score techniques to compare surgical treatment with nonoperative treatment in 127 patients with symptomatic rotator cuff tears.2 At the 18-month follow-up, patients who underwent operative treatment had significantly better shoulder pain and function outcomes than those who underwent nonoperative treatment.

Anterior Cruciate Ligament (ACL)
–A large prospective multicenter study investigating how rehabilitation factors affect the risk of revision ACL procedures after primary reconstruction yielded good news and bad news about the use of an ACL derotational brace for return to activity. Good: Those using the brace had much-improved KOOS scores at 2 years. Bad: Use of the brace doubled the odds of requiring another surgery within 2 years.

Total Knee Arthroplasty (TKA)
–A randomized controlled trial (RCT) of >300 patients who underwent TKA compared traditional in-home or at-clinic rehabilitation with virtual rehabilitation. The 3 main findings after 12 weeks were as follows:

  • The virtual rehab group had a significantly lower median cost.
  • Virtual rehab was not inferior based on KOOS assessments.
  • There were fewer rehospitalizations in the virtual-rehab group.

Orthobiologics
–An RCT compared the efficacy of an ultrasound-guided injection of leukocyte-rich platelet-rich plasma (PRP), leukocyte-poor PRP, and a control saline injection to treat patellar tendinopathy.3 At the 1-year follow-up, neither PRP formulation was found to be more efficacious than the control injection.

References

  1. Uda K, Matsui H, Fushimi K, Yasunaga H. Intensive in-hospital rehabilitation after hip fracture surgery and activities of daily living in patients with dementia: retrospective analysis of a nationwide inpatient database. Arch Phys Med Rehabil.2019 Dec;100(12):2301-7.
  2. Jain NB, Ayers GD, Fan R, Kuhn JE, Warner JJP, Baumgarten KM, Matzkin E, Higgins LD. Comparative effectiveness of operative versus nonoperative treatment for rotator cuff tears: a propensity score analysis from the ROW cohort. Am J Sports Med.2019 Nov;47(13):3065-72. Epub 2019 Sep 13.
  3. Scott A, LaPrade RF, Harmon KG, Filardo G, Kon E, Della Villa S, Bahr R, Moksnes H, Torgalsen T, Lee J, Dragoo JL, Engebretsen L. Platelet-rich plasma for patellar tendinopathy: a randomized controlled trial of leukocyte-rich PRP or leukocyte-poor PRP versus saline.

September 2020 Article Exchange with JOSPT

For the last 6 years, JBJS has participated in an “article exchange” collaboration with the Journal of Orthopaedic & Sports Physical Therapy (JOSPT) to support multidisciplinary integration, continuity of care, and excellent patient outcomes in orthopaedics and sports medicine.

During the month of September 2020, JBJS and OrthoBuzz readers will have open access to the JOSPT systematic review titled “Meniscus or Cartilage Injury at the Time of Anterior Cruciate Ligament Tear Is Associated with Worse Prognosis for Patient-Reported Outcome 2 to 10 Years after Injury.”

The authors of this systematic review conclude that “patients, physical therapists, orthopaedic surgeons, and athletic trainers [should] be aware that concomitant meniscus or cartilage injuries may lead to worse knee function 2 to 10 years after ACL reconstruction.”

May 2020 Article Exchange with JOSPT

For the last 6 years, JBJS has participated in an “article exchange” collaboration with the Journal of Orthopaedic & Sports Physical Therapy (JOSPT) to support multidisciplinary integration, continuity of care, and excellent patient outcomes in orthopaedics and sports medicine.

During the month of May 2020, JBJS and OrthoBuzz readers will have open access to the JOSPT article titled “Athletes with Bone-Patellar Tendon-Bone Autograft for ACL Reconstruction Were Slower to Meet Rehabilitation Milestones and Return-to-Sport Criteria than Athletes with Hamstring Tendon Autograft or Soft Tissue Allograft.”

Although the title reveals the findings of this retrospective cohort study, the authors emphasize that “athletes in the allograft and HT groups may be at higher risk of sustaining another knee injury when they return to sport…than those in the BPTB group.” Also, all 79 participants in the study were athletes planning to return to level 1 or 2 sporting activities, so these findings may not be generalizable to all athletes.

What’s New in Sports Medicine 2020

Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of OrthoBuzz summaries of these “What’s New” articles. This month, co-author Christopher Y. Kweon, MD selected the 5 most clinically compelling findings from the 40 studies summarized in the April 15, 2020 “What’s New in Sports Medicine.

ACL Graft Choice
—A randomized controlled trial (RCT) comparing bone-tendon-bone autograft, quadrupled hamstring tendon autograft, and double-bundle hamstring autograft for ACL reconstruction in young adults found the following:

  • No between-group differences in patient-reported quality-of-life scores at 5 years
  • Significantly higher rates of traumatic graft reinjuries in the hamstring-tendon and double-bundle groups
  • Relatively low (37%) return to preinjury level of activity for the entire population, with no significant between-group differences

Meniscal Repairs with Bone Marrow Venting
—A double-blinded RCT1 of patients with complete, unstable, vertical meniscal tears compared isolated meniscal repair to meniscal repair with a bone marrow venting procedure (BMVP). Meniscal healing, as assessed with second-look arthroscopy at a mean of 35 weeks, was 100% in the BMVP group and 76% in the control group (p = 0.0035). Secondary pain and function measures at 32 to 51 months were also better in the BMVP group.

Rotator Cuff Repair Rehab
—A multisite RCT2 among >200 patients who received arthroscopic repair of a full-thickness rotator cuff tear compared standard rehabilitation (patients wore a sling at all times except when performing prescribed exercises) and early mobilization (patients wore a sling only when needed for comfort). Early mobilizers showed significantly better forward flexion and abduction at 6 weeks, but no subjective or objective differences (including retear rate) were found at any other time points.

Remplissage for Anterior Shoulder Instability
—A systematic review3 of studies investigating arthroscopic Bankart repair with and without remplissage found significantly higher instability-recurrence rates with isolated Bankart repair. Overall, the addition of remplissage appears to yield better patient-reported function scores compared with isolated Bankart repair alone.

Syndesmotic Ankle Injuries
—A meta-analysis of 7 RCTs (335 patients)4 comparing dynamic versus static fixation for syndesmotic injuries of the ankle found that the overall risk of complications was significantly lower in the dynamic fixation group. Reoperation rates were similar in the two groups, but implant breakage or loosening was reduced with dynamic fixation devices. Compared with static fixation, the dynamic fixation group also had higher AOFAS scores and lower VAS scores at various time points.

References

  1. Kaminski R, Kulinski K, Kozar-Kaminska K, Wasko MK, Langner M, Pomianowski S. Repair augmentation of unstable, complete vertical meniscal tears with bone marrow venting procedure: a prospective, randomized, double-blind, parallel-group, placebo-controlled study. Arthroscopy.2019 May;35(5):1500-1508.e1. Epub 2019 Mar 20.
  2. Sheps DM, Silveira A, Beaupre L, Styles-Tripp F, Balyk R, Lalani A, Glasgow R, Bergman J, Bouliane M; Shoulder and Upper Extremity Research Group of Edmonton (SURGE). Early active motion versus sling immobilization after arthroscopic rotator cuff repair: a randomized controlled trial. Arthroscopy.2019 Mar;35(3):749-760.e2.
  3. Lazarides AL, Duchman KR, Ledbetter L, Riboh JC, Garrigues GE. Arthroscopic remplissage for anterior shoulder instability: a systematic review of clinical and biomechanical studies. Arthroscopy.2019 Feb;35(2):617-28. Epub 2019 Jan 3.
  4. Grassi A, Samuelsson K, D’Hooghe P, Romagnoli M, Mosca M, Zaffagnini S, Amendola A. Dynamic stabilization of syndesmosis injuries reduces complications and reoperations as compared with screw fixation: a meta-analysis of randomized controlled trials. Am J Sports Med.2019 Jun 12. [Epub ahead of print].

What’s New in Pediatric Orthopaedic Surgery 2020

Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of OrthoBuzz summaries of these “What’s New” articles. This month, co-author Kelly Vanderhave, MD selected the 5 most clinically compelling findings from the more than 50 studies summarized in the February 19, 2020 “What’s New in Pediatric Orthopaedic Surgery.

ACL Reconstruction
—ACL reconstruction in pediatric patients continues to receive research attention. A recent review of >560 cases showed that soft-tissue grafts used in this population were twice as likely to fail (13%) as patellar tendon grafts (6%) (p <0.001).1

Septic Arthritis of the Hip
—A multicenter study identified the following independent risk factors for a repeat surgical procedure after initial arthrotomy for septic arthritis of the hip: presenting CRP of >10 mg/dL and ESR of >40 mm/hr, and the presence of osteomyelitis and MRSA.2

Adolescent Idiopathic Scoliosis
—A minimum 20-year follow-up of a cohort study evaluating 180 patients after observation, bracing, or surgical management of adolescent idiopathic scoliosis found the following:

  • In the observation cohort, 5 of 36 patients underwent a scoliosis surgical procedure as an adult.
  • In the bracing cohort, only 1 of 41 patients required an additional spinal surgical procedure.
  • In the surgical cohort, 7 of 103 patients required a revision surgical procedure.

At a mean follow-up of 30 years, there were no significant differences in patient-reported outcomes between the 3 cohorts.3

Infection after Spinal Deformity Surgery
—A retrospective study of >600 pediatric patients who underwent spinal deformity surgery identified 2 independent risk factors among 11 cases of deep surgical site infection that occurred >3 months after the procedure:

  • Nonidiopathic scoliosis (e.g., neuromuscular, congenital, and syndromic etiologies)
  • High volume of crystalloid administered during surgery (mean of 3.3 ±1.2 L in the group with surgical site infections vs 2.4 ±1.0 L in the infected group)

Redosing antibiotics intraoperatively after 3 hours did not significantly influence the risk of infection.4

Hip Dislocations in Infants with CP
—Among 11 patients (15 hips) with spastic cerebral palsy whose preoperative mean acetabular index was 29°, surgical hip reconstruction (a combination of open reduction, adductor tenotomy, femoral osteotomy, and/or pelvic osteotomy) yielded the following results at a mean follow-up of 40 months:

  • Mean migration index of 7%
  • Mean acetabular index of 22°
  • No instances of osteonecrosis
  • 90% achievement and maintenance of hip reduction in those who underwent open reduction with or without pelvic or femoral osteotomy.5

References

  1. Ho B, Edmonds EW, Chambers HG, Bastrom TP, Pennock AT. Risk factors for early ACL reconstruction failure in pediatric and adolescent patients: a review of 561 cases. J Pediatr Orthop. 2018 Aug;38(7):388-92.
  2. Murphy RF, Plumblee L, Barfield WB, Murphy JS, Fuerstenau N, Spence DD, Kelly DM, Dow MA, Mooney JF 3rd. Septic arthritis of the hip-risk factors associated with secondary surgery. J Am Acad Orthop Surg. 2019 May 1;27(9):321-6.
  3. Larson AN, Baky F, Ashraf A, Baghdadi YM, Treder V, Polly DW Jr, Yaszemski MJ. Minimum 20-year health-related quality of life and surgical rates after the treatment of adolescent idiopathic scoliosis. Spine Deform. 2019 May;7(3):417-27.
  4. Du JY, Poe-Kochert C, Thompson GH, Son-Hing JP, Hardesty CK, Mistovich RJ. Risk factors for early infection in pediatric spinal deformity surgery: a multivariate analysis. Spine Deform. 2019 May;7(3):410-6.
  5. Refakis CA, Baldwin KD, Spiegel DA, Sankar WN. Treatment of the dislocated hip in infants with spasticity. J Pediatr Orthop. 2018 Aug;38(7):345-9.

Precise Pivot-Shift Data Shines New Light on Partial ACL Tears

Concern, conversations, and controversy still exist around the optimal treatment for a partial anterior cruciate ligament (ACL) tear. Many surgeons recommend nonoperative treatment, despite evidence that up to 40% of those patients progress to a complete tear. Then again, surgical management comes with an ample array of possible complications. In the February 5, 2020 issue of The Journal of Bone & Joint Surgery, Lian et al. add insight into how best to treat partial ACL tears with their study of rotatory knee laxity in >300 patients with varying severities of ACL injury.

As part of the research undertaken by the PIVOT Study Group, Lian et al. made precise measurements of lateral knee compartment translation (measured with image-based iPad software; see Figure) and lateral compartment acceleration (measured with a surface-mounted accelerometer) during preoperative pivot-shift testing of affected and healthy knees in patients under anesthesia who had the following ACL problems:

  • A partial ACL tear (n=20)
  • A complete ACL tear (n=257)
  • A failed ACL reconstruction (n=27)

With each increasing grade of injury, the authors found  progressively increased rotatory laxity, defined as an increased difference in affected-knee-versus-healthy-knee lateral translation and acceleration. They also found a progressive, injury grade-related increase in lateral knee compartment translation in the healthy knees of these patients. In addition, the data suggest that patients who experience a failed ACL reconstruction exhibit increased rotatory knee laxity prior to the event that precipitated the failure.

From these findings and previous evidence that persistent rotatory knee laxity correlates with reduced patient-reported outcome scores and increased rates of meniscal and cartilage damage among patients with ACL injuries, Lian et al. conclude that “an elevated quantitative pivot shift in the case of a partial ACL tear might be an indication for bundle augmentation or ACL reconstruction.”

Vancomycin-Soaked ACL Grafts Cut Already-Low Infection Rates

The word “infection” contains 9 letters, but it’s a four-letter word for orthopaedic surgeons. Postoperative infections are complications that we all deal with, but we try hard to avoid them. Infections after elective sports surgeries can have especially devastating long-term consequences. Thankfully, scientific advances such as  improved sterile techniques and more powerful prophylactic antibiotics have helped us decrease the rates of perioperative infections. But more can always be done in this arena.

Baron et al. discuss one additional infection-fighting approach in the December 18, 2019 issue of JBJS, where they report on findings from a retrospective cohort study that looked at 90-day infection rates after >1,600 anterior cruciate ligament (ACL) reconstructions. Specifically, they investigated whether the rates of infection differed when the ACL grafts were prepared with or without a vancomycin irrigant. The average patient age was 27 years old, and all the surgeries (84.1% of which were primary reconstructions) were performed by 1 of 6 fellowship-trained surgeons. The graft was soaked in vancomycin solution in 798 cases (48.7%), while the remaining 51.3% did not use vancomycin.

Baron et al. found that 11 of the reconstructions were complicated by infection within 90 days, but only 1 of those 11 infections occurred in the vancomycin group (p=0.032). After controlling for various confounding factors, the authors found that increased body mass index and increased operative time were also significantly associated with postoperative infection, while age, sex, smoking, surgeon, and insurance type were not.

These results reveal an 89.4% relative risk reduction in postoperative infections after ACL reconstructions when grafts are bathed in vancomycin solution, although the absolute rate of infection among non-soaked grafts (1.2%) was still quite low. Time and more rigorous study designs will tell us whether this is a big step forward in the evolution of infection prevention, but these results should at least prompt further investigation.

Matthew R. Schmitz, MD
JBJS Deputy Editor for Social Media

ACL Grafts: Diameter Does Matter, Sort Of

Clinical failure of anterior cruciate ligament (ACL) reconstructions continues to be a too-common scenario. The increasing incidence of ACL revision is due to a variety of factors, including greater intensity of postsurgical physical activity, technical issues, and anatomical influences of the proximal tibia and distal femur. Registries are important sources of data for ACL-related investigations, but I think they are most useful in clarifying experimental designs for more sophisticated clinical research.

In a cohort study in the October 16, 2019 issue of The Journal, Snaebjornsson et al. examined the influence of ACL graft diameter on the risk of revision surgery over 2 years in >18,000 subjects whose data resided in the national knee ligament registries of Sweden and Norway. The vast majority of those patients (92.8%) received a hamstring autograft, with 7.2% receiving a patellar tendon autograft. Overall, the 2-year rate of ACL revision was 2.63% for patellar tendon autografts and 2.08% for hamstring autografts, a statistically nonsignificant difference in relative risk.

However, the authors found an important correlation between graft diameter in the hamstring tendon cohort, with autografts <8 mm in diameter being associated with a higher risk of revision, compared with larger-diameter hamstring autografts. Additionally, patients treated with hamstring graft diameters of ≥9 mm or ≥10 mm had a lower risk of ACL revision surgery than those treated with patellar tendon grafts of any size.

One key limitation that should influence our interpretation of this study is a lack of detail regarding how compliant surgeons were intraoperatively with the use of the measurement device that is depicted in the manuscript and shown above. In addition, the limitations of registry data did not permit the authors to adjust for postsurgical exposures, such as return to sport, the increasing intensity of which makes rerupture more likely. Additional relevant information that would have aided interpretation of the findings includes the relative size of the tibia and femur, lateral condyle size and shape, and proximal tibial slope.

Despite these limitations, this study should prompt further research that uses robust clinical designs to more fully investigate the impact of graft diameter on ACL rerupture rates.

Marc Swiontkowski, MD
JBJS Editor-in-Chief

What’s New in Sports Medicine 2019

Every month, JBJS publishes a review of the most pertinent and impactful studies published in the orthopaedic literature during the previous year in 13 subspecialties. Click here for a collection of all OrthoBuzz Specialty Update summaries.

This month, Albert Gee, MD, a co-author of the April 17, 2019 “What’s New in Sports Medicine,” selected the five most clinically compelling findings from among the 30 noteworthy studies summarized in the article.

Anterior Cruciate Ligament (ACL) Reconstruction

–Norwegian researchers randomized 120 patients to undergo either single-bundle or double-bundle ACL reconstruction and followed them for 2 years.1 They found no difference between the 2 techniques in any patient-reported outcome, knee laxity measurements, or activity levels. These results, along with the preponderance of evidence from other comparative trials over the last 5 years, strongly suggest that routine use of 2 bundles to primarily reconstruct a torn ACL adds no clinical benefit over a well-positioned single-bundle reconstruction.

Knee Cartilage Repair

–A randomized study compared long-term patient outcomes after knee cartilage repair using microfracture versus mosaicplasty.2 Included patients had 1 or 2 focal femoral lesions measuring between 2 and 6 cm2. Better outcomes after a minimum of 15 years of follow-up were found in the mosaicplasty group. Although there were only 20 patients in each arm, the Lysholm-score differences between the groups were both clinically important and statistically significant. More patients in the mosaicplasty group than in the microfracture group said they would have the surgery again, knowing their 15-year outcome.

Rotator Cuff

–UK researchers randomized 313 patients with ≥3 months of subacromial pain and an intact rotator cuff who had completed a nonoperative program of physical therapy and injection to 1 of 3 groups: arthroscopic subacromial decompression, diagnostic arthroscopy (“sham” surgery), or no intervention.3 At 6 months and 1 year, all groups demonstrated statistically significant and clinically important improvement, but patient-reported outcome scores were significantly better in both surgical groups compared with the no-treatment group. The data suggest that patients such as these improve over time, regardless of management, but that surgical decompression  may offer a slight benefit over nonoperative management because of the placebo effect.

–A randomized controlled trial investigated the effect of a formal preoperative education program (2-minute video plus handout)4 about postoperative narcotic use, side effects, dependence risk, and addiction potential among >130 patients undergoing arthroscopic rotator cuff repair surgery. The education group consumed 33% less narcotic medication at 6 weeks and 42% less at 12 weeks compared with the control group. Among the more than one-quarter of the patients who had used opioids prior to surgery, those randomized to the education group were 6.8 times more likely than controls to discontinue narcotic use during the study period.

Hip Arthroscopy

–A randomized controlled trial of >300 patients compared hip arthroscopy and “best conservative care” for treating femoroacetabular impingement (FAI).5 Only 8% of patients crossed over from conservative care to the surgical group. The mean adjusted difference in iHOT-33 scores at 1 year was 6.8, in favor of hip arthroscopy. However, adverse events were more frequent in the arthroscopy cohort, and a within-trial economic evaluation suggested that hip arthroscopy was not cost-effective compared with conservative care during the 1-year trial period.

References

  1. Aga C, Risberg MA, Fagerland MW, Johansen S, Trøan I, Heir S, Engebretsen L. No difference in the KOOS Quality of Life Subscore between anatomic double-bundle and anatomic single-bundle anterior cruciate ligament reconstruction of the knee: a prospective randomized controlled trial with 2 years’ follow-up. Am J Sports Med.2018 Aug;46(10):2341-54. Epub 2018 Jul 18.
  2. Solheim E, Hegna J, Strand T, Harlem T, Inderhaug E. Randomized study of long-term (15-17 years) outcome after microfracture versus mosaicplasty in knee articular cartilage defects. Am J Sports Med.2018 Mar;46(4):826-31. Epub 2017 Dec 18.
  3. Beard DJ, Rees JL, Cook JA, Rombach I, Cooper C, Merritt N, Shirkey BA, Donovan JL, Gwilym S, Savulescu J,Moser J, Gray A, Jepson M, Tracey I, Judge A, Wartolowska K, Carr AJ; CSAW Study Group. Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial. Lancet. 2018 Jan 27;391(10118):329-38. Epub 2017 Nov 20.
  4. Syed UAM, Aleem AW, Wowkanech C, Weekes D, Freedman M, Tjoumakaris F, Abboud JA, Austin LS. Neer Award 2018: the effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial. J Shoulder Elbow Surg.2018 Jun;27(6):962-7. Epub 2018 Mar 26.
  5. Griffin DR, Dickenson EJ, Wall PDH, Achana F, Donovan JL, Griffin J, Hobson R, Hutchinson CE, Jepson M,Parsons NR, Petrou S, Realpe A, Smith J, Foster NE; FASHIoN Study Group. Hip arthroscopy versus best conservative care for the treatment of femoroacetabular impingement syndrome (UK FASHIoN): a multicentre randomised controlled trial. Lancet. 2018 Jun 2;391(10136):2225-35. Epub 2018 Jun 1.