Bioabsorbable Versus Metallic Interference Screws in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Overlapping Meta-analyses

doi:10.1016/j.arthro.2014.11.011

Arthroscopy: The Journal of Arthroscopic & Related Surgery

Volume 31, Issue 3, March 2015, Pages 561-568

https://doi.org/10.1016/j.arthro.2014.11.011 Get rights and content

Purpose

Multiple meta-analyses of randomized controlled trials have been conducted to compare clinical and functional outcomes after anterior cruciate ligament (ACL) reconstruction using metallic interference screw (MIS) versus bioabsorbable interference screw (BIS) fixation, but discrepancies in their findings have prevented a consensus conclusion. The purposes of this study were (1) to conduct a systematic review of meta-analyses comparing MISs and BISs in ACL reconstruction, (2) to provide surgical treatment recommendations for ACL graft fixation based on the highest available evidence, and (3) to propose future research avenues in areas of practice lacking high-level evidence.

Methods

The literature was systematically reviewed to identify meta-analyses comparing MISs and BISs in ACL reconstruction. Data were extracted for clinical and functional outcomes, and methodologic quality was assessed using the validated Quality of Reporting of Meta-analyses and Oxman-Guyatt systems. To determine which meta-analyses provided the current best available evidence, the Jadad decision algorithm was used.

Results

One Level I and 2 Level II meta-analyses were included. None showed differences between BISs and MISs in validated outcome scores, pivot-shift testing, KT arthrometry (MEDmetric, San Diego, CA), or loss of knee motion. Subgroup analyses found no differences in clinical outcomes or knee stability across biomaterials. All meta-analyses were of high quality according to the Quality of Reporting of Meta-analyses and Oxman-Guyatt systems. Two meta-analyses were determined by the Jadad algorithm to represent the current best available evidence. Both studies showed prolonged knee effusion with BIS use, with 1 also showing an increased incidence of femoral tunnel widening and screw breakage with BIS use.

Conclusions

Whereas clinical and functional outcomes are similar with MISs and BISs, prolonged knee effusion, femoral tunnel widening, and screw breakage are more common with BIS use. Future cost-effectiveness analyses may help weigh the known advantages of BISs against their costs and adverse-event profile.

Level of Evidence

Level II, systematic review of Level I and II studies.

Section snippets

Methods

The English-language literature was searched on March 12, 2014, using the following databases: PubMed, Embase, and the Cochrane Database of Systematic Reviews. The following key words were used: “bioabsorbable,” “metallic OR metal,” and “anterior cruciate ligament.” General search terms were used to ensure thorough study inclusion. The resultant study titles and abstracts were reviewed and manually cross-referenced to identify all potentially eligible studies. The inclusion criteria were (1)

Results

The initial search of terms resulted in 52 total articles (Fig 1), of which 3 studies published between 2010 and 2014 met the eligibility criteria.24, 25, 26 They consisted of 1 Level I study²⁵ and 2 Level II studies.24, 26 No conflict of interest was present in any study. All studies performed heterogeneity analytics. The total sample size ranged from 711 patients²⁴ to 790 patients.²⁶ The follow-up periods included in these studies ranged from 12 months25, 26 to 96 months.²⁴ The follow-up rate

Discussion

The major findings of this study were prolonged knee effusion, increased femoral tunnel widening, and increased screw breakage associated with BIS use. This study did not assess cost aspects associated with BIS use versus MIS use.

With an increasing number of ACL reconstructions performed annually, it is critical that the procedure be performed in a manner that provides the patient with the best chance for successful clinical and functional outcomes with the lowest rate of adverse events. Many

Conclusions

Ultimately, the meta-analyses with the best available evidence showed prolonged knee effusion, increased femoral tunnel widening, and increased screw breakage with BIS use. In a health care generation particularly conscious of cost-effectiveness, further detailed analyses of the cost-benefit ratio of BISs compared with MISs would be valuable in making further definitive recommendations for or against the continued use of BISs in specific situations or in particular patient populations in which

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Metal vs non-metal fixation methods for patellar fractures: A systematic review and meta-analysis of clinical and radiographic outcomes
2023, Journal of Clinical Orthopaedics and Trauma
This paper aims to systematically review and meta-analyse the available evidence regarding the clinical and radiographic outcomes of non-metal fixation methods in treating patellar fractures compared to a control metal fixation group, in the hopes of bringing insight into their effectiveness.
Two investigators systematically reviewed studies across 9 English or Mandarin electronic databases - Cochrane Library, EMBASE, Google Scholar, Medline, PubMed, Scopus, Web of Science, CNKI and Wanfang Data, in adherence to PRISMA guidelines. The inclusion criteria for study selection were: English or Mandarin comparative studies that evaluated clinical (Patient Reported Outcome Measures, incidence of reoperations and postoperative complications) or radiographic (time to union and incidence of secondary loss of reduction) outcomes of metal and non-metal fixation methods for patellar fractures. From an initial pool of 1269 studies, 19 studies involving 1612 patients were included in the meta-analysis after full-text evaluation and accounting for exclusion criteria.
Clinically, the reduction in reoperations (OR = 0.22, 95% CI [0.10, 0.51], P = 0.0003), direct (OR = 0.17, 95% CI [0.08, 0.33], P < 0.00001) and indirect (OR = 0.50, 95% CI [0.27, 0.93], P = 0.03) implant-related postoperative complications were significantly in favor of non-metal fixation. Radiographically, the decrease in time to union (SMD = −0.79, 95% CI [-1.11, −0.47], P < 0.00001) in the non-metal group compared to the metal group was also significant. The remaining results were comparable.
This meta-analysis suggests that non-metallic internal fixation had similar if not superior outcomes to their metallic counterparts, with fewer implant-related complications and improved postoperative recovery. Given the higher re-operation rates associated with metallic fixation, non-metallic methods may be preferable from economic and safety perspectives. Nevertheless, more homogenous studies with standardised fracture configurations and treatment modalities are needed before declaring non-metallic fixation as the gold standard for patellar fractures.
Anterior cruciate ligament reconstruction with a biocomposite interference screw maintains graft fixation survival and improves clinical outcomes at 1 year: A multicenter prospective case series
2023, Heliyon
A biocomposite interference screw with an open architecture was developed to provide a greater available surface area for bone ingrowth compared with conventional solid interference screws. We herein describe a prospective, single-cohort study conducted using this interference screw in anterior cruciate ligament (ACL) reconstruction. Sixty subjects (mean age, 34.9 years; standard deviation, 10.6) undergoing ACL repair using the biocomposite interference screw were enrolled at 3 sites in the United States. Subjects were followed preoperatively (baseline) and postoperatively at 6 months and 1 year. The primary endpoint was graft fixation survival rate at 6 months and 1 year. Secondary endpoints included graft survival (failure defined as that occurring for any reason); International Knee Documentation Committee (IKDC) score (exam and subjective forms); Tegner Activity form; Lysholm score; and EQ (EuroQuol)-5D-5L index score and visual analogue scale. There was a 100 % rate of graft fixation survival at 6 months (54/54; 95 % confidence interval [CI]: 100-100) and 1 year (50/50; 95 % CI: 100-100). One patient experienced a complete tear of the ACL 5 months following index surgery, resulting in graft survival rates of 98.1 % (53/54; 95 % CI: 94.6–100) at 6 months at 98.0 % (49/50; 95 % CI: 94.1–100) at 1 year. Significant improvements (p < .0001) were obtained between baseline and 6 months for the majority of patient-reported outcomes, and were maintained out to 1-year follow up. There was no significant difference over baseline in the IKDC sub-scale of symptoms. Nine patients (15.0 %) experienced serious adverse events during the course of the study; three of these patients’ adverse events were considered possibly or definitely related to the procedure device (ACL tear, pulmonary embolism/deep vein thrombosis, and a patellar fracture). In conclusion, this biocomposite interference screw has a favorable safety and efficacy profile at 1 year, with no failures of graft fixation, noted during that time.
Both low and high knee flexion angles during tibial graft fixation yield comparable outcomes following ACL reconstruction with quadriceps tendon autograft: A systematic review
2022, Journal of ISAKOS
A paucity of clinical evidence surrounds the effect of the knee flexion angle during tibial fixation of the graft during anterior cruciate ligament (ACL) reconstruction. While biomechanical studies have recently sought to revive this area of study in both single- and double-bundle graft populations, they have done so using variants of the hamstring graft. This does not shed light on the optimal fixation of other autograft options, namely, the quadriceps tendon (QT) autograft.
To determine the effect of the knee flexion angle during tibial graft fixation on functional and clinical outcomes following ACL reconstruction using single-bundle QT autograft, inclusive of both soft-tissue and bone-plug graft types.
An electronic search of MEDLINE, EMBASE, Web of Science, and the Cochrane Library was carried out from database inception to June 2020. Following study screening, patient demographics and fixation technique as well as both subjective and objective clinical outcomes were abstracted. Studies were divided based on the knee flexion angle during tibial fixation of the graft. The low knee flexion angle (L-KFA) group included patients with a tibial fixation angle of < 30° of flexion, and the high knee flexion (H-KFA) group included those with a tibial fixation of exactly 30° of flexion. The data were qualitatively synthesized due to significant heterogeneity across the included studies.
Sixteen studies (1,169 patients) were included for analysis. There were 675 patients in the L-KFA group (mean age range, 18.7–34.5 years) and 494 patients in the H-KFA group (mean age range, of 23.2–32.1 years). Both groups yielded statistically significant improvements from preoperative to postoperative scores across several functional and clinical outcomes. Return to pre-injury activity levels ranged from 64% to 81% in L-KFA studies and from 73.3% to 86.7% in H-KFA studies. All-cause graft failure rates ranged from 1.4% to 4.3% in L-FKA studies and from 0%–10.7% in H-KFA studies.
Both low- and high-knee flexion angles during tibial graft fixation produce improved postoperative clinical and functional outcomes with comparable outcomes across groups. There is inconclusive evidence to recommend the ideal knee flexion angle for graft fixation in primary ACLR.
Level IV.
Early cost estimating model for new bioabsorbable orthopedic implant candidates: A theoretical study
2021, Journal of the Mechanical Behavior of Biomedical Materials
Citation Excerpt :
Several HTA studies were performed to evaluate currently available bioabsorbable orthopedic implants, aiming to recommend their adoption in the clinical practice. These are economic studies (e.g. cost-effective analysis and cost-benefit analysis) or meta-analysis studies that compare, for each orthopedic application, the outcomes of using bioabsorbable implants in treatment strategies, usually against the use of metallic implants (Bakelen et al., 2015; Eng et al., 2015; Mascarenhas et al., 2015; Shen et al., 2010). Regarding the early HTA, scant literature is available for the development of new bioabsorbable implants.
An early health technology assessment (HTA) study was performed to assess the need for developing a new bioabsorbable implant for the treatment of specific orthopedic injuries. The Anterior Cruciate Ligament Reconstruction (ACLR) procedure was selected based on the need and potential impact of bioabsorbable implants in the treatment of ACL injuries. The economic model considers the possible health events after an ACLR (failures and other complications such as stiffness and pain). A decision tree approach was used, and several sensitivity analyses were performed using a Monte Carlo simulation. A cost estimating model was applied comparatively for currently available metal and bioabsorbable implants against a potential new bioabsorbable implant with improved performance. A reduction in stiffness and pain symptoms were considered as targets for these new implants performance, with reduced inflammation resulting from the use of materials with appropriate biological and mechanical properties.
The current study estimates that, under the assumptions made, the introduction of a new bioabsorbable implant in ACLR surgeries may generate yearly cost savings. The model estimates positive cost-benefits of the new implant when it reduces the probability of failure by more than 30%, or reduces at least 14% the probability of complications of an inflammatory nature. The development of a new bioabsorbable orthopedic implant for ACLR is encouraged by this study identifying the need for new bioabsorbable implants with improved biological and mechanical performance.
The results of this early HTA have made it possible to anticipate design needs and objectives for the research and development of new orthopedic bioabsorbable implants.
Comparative Risk-Benefit Profiles of Individual Devices for Graft Fixation in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Network Meta-analysis
2020, Arthroscopy - Journal of Arthroscopic and Related Surgery
Citation Excerpt :
To date, several conventional meta-analyses have assessed the efficacy and safety of different devices for graft fixation.16,23-26,50-52 Of these, 3 showed similar efficacy between bio-screws and metal screws,23,26,52 but bio-screws may be associated with more treatment failures.23 Two showed no significant difference in terms of clinical outcomes between a cross pin and an interference screw24 or between a cross pin and a cortical button.25
To compare the efficacy and safety of individual devices for femoral and/or tibial graft fixation in anterior cruciate ligament (ACL) reconstruction.
The PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to December 12, 2018. Randomized controlled trials comparing individual devices for ACL graft fixation were included. Bayesian network meta-analysis was performed to assess the efficacy profile using the following outcomes: Lysholm score, International Knee Documentation Committee (IKDC) category, laxity, range of motion, and Tegner score. The incidence of infection, effusion, and graft rupture for each device was reported.
We included 57 randomized controlled trials involving 4,304 patients aged 23.8 to 40.9 years. The female proportion ranged from 0% to 100%. The length of follow-up ranged from 6 to 144 months. Of the 13 studied femoral fixation devices, none was significantly different from the others regarding the Lysholm score, IKDC category, range of motion, and Tegner score. Bioabsorbable interference screws (standardized mean difference, 1.3; 95% credible interval, 0.0-2.5) showed higher laxity than the EndoPearl at a borderline level of statistical significance, but the difference varied substantially within multiple sensitivity analyses. Infection (2.0%) was most commonly seen with the EndoPearl, whereas the bone mulch screw had the highest incidence of effusion (5.5%) and graft rupture (5.5%). For the 9 studied tibial fixation devices, no significant difference was observed in the aforementioned efficacy measurements. Bioabsorbable interference screws with staples had the highest incidence of infection (11.1%) and effusion (15.6%), whereas graft rupture was most commonly seen with the bone plug (4.0%).
Graft fixation devices in ACL reconstruction share a similar efficacy profile in terms of the Lysholm score, IKDC category, range of motion, and Tegner score but not laxity. On the other hand, safety profiles seem to vary among different devices. These findings can support surgeons, alongside their experience and preference, as well as the relative cost of each device, in delivering an individualized plan for an optimal operation.
Level II, meta-analysis of Level I and II studies.
Complications With Fixation Devices in Anterior Cruciate Ligament Surgery
2020, Complications in Orthopaedics: Sports Medicine
The goal of graft fixation in anterior cruciate ligament (ACL) reconstruction is to provide initial strength and stiffness to allow for early rehabilitation until biologic fixation occurs in the bone tunnel. No ACL graft fixation device is ideal, and the advantages and disadvantages of each must be weighed by the surgeon before deciding on the device to be used for a particular patient. This chapter highlights several commonly used ACL fixation devices and complications associated with their use.

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: The authors report the following potential conflict of interest or source of funding: N.N.V. receives support from Smith & Nephew, Vindico Medical, Major League Baseball, and Omeros and is part of a sports fellowship that receives support from Arthrex, Smith & Nephew, Össur, and Linvatec. B.J.C. receives support from Arthrex, DJ Orthopaedics, Johnson & Johnson, Regentis, Zimmer, Medipost, Smith & Nephew, Carticept, and Regentis. C.B-J. receives support from The Foundry as an unpaid consultant. B.R.B. receives support from Arthrex, ConMed Linvatec, DJ Orthopaedics, Össur, Smith & Nephew, and Tornier.

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Systematic ReviewBioabsorbable Versus Metallic Interference Screws in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Overlapping Meta-analyses

Purpose

Methods

Results

Conclusions

Level of Evidence

Section snippets

Methods

Results

Discussion

Conclusions

Arthroscopy

Arthroscopy

Arthroscopy

Knee

Knee

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Lancet

J Clin Epidemiol

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

Arthroscopy

An international survey on anterior cruciate ligament reconstruction practices

Int Orthop

Vascularized patellar tendon graft with rigid internal fixation for anterior cruciate ligament insufficiency

Clin Orthop Relat Res

Comparison of failure strength between metallic and absorbable interference screws. Influence of insertion torque, tunnel-bone block gap, bone mineral density, and interference

Am J Sports Med

Transplant fixation by anterior cruciate ligament reconstruction. Metal vs. bioabsorbable polyglyconate interference screw. A prospective randomized study of 40 patients

Unfallchirurg

Fixation of patellar tendon bone graft in reconstruction of patellar ligaments. Comparison of bioabsorbable and metal interference screws—Results of treatment

Ortop Traumatol Rehabil

Systematic Review
Bioabsorbable Versus Metallic Interference Screws in Anterior Cruciate Ligament Reconstruction: A Systematic Review of Overlapping Meta-analyses