Biodegradable materials, including natural and synthetic polymers and hydrolyzable metals, constitute the main components of temporary, implantable medical devices. Besides the intrinsic properties of the materials, the most critical factor determining the successful clinical outcome of implantable and degradable devices is the host response, particularly the immune response, which largely depends on the material features and degradation mechanisms. In this Review, we first survey the state of the art in terms of materials options for use in biodegradable medical devices, focusing on degradation mechanisms and their control. In particular, we highlight silk, which is emerging as an important polymer, owing to its mechanical robustness, bioactive component sequestration, degradability without problematic metabolic products and biocompatibility. We then discuss the host response to these biodegradable materials in terms of dynamic tissue–implant interfaces. Next, we examine the clinical translation of three leading biodegradable material systems — natural and synthetic biodegradable polymers and biodegradable metals — and the related challenges in the context of orthopaedic fixation devices, cardiovascular stents and biodegradable electronic devices. Looking to the future, we propose updated material design strategies to improve the clinical outcomes for these biodegradable medical devices. Clinical outcomes with implantable and degradable devices largely depend on host response. This Review surveys material options and degradation mechanisms relevant to host responses to biodegradable devices, examines clinical translation of leading biodegradable materials and proposes updated material-design strategies to improve device performance.

Design of biodegradable, implantable devices towards clinical translation

Background: Three different techniques of anterior cruciate ligament (ACL) reconstruction—conventional (transtibial) single bundle (CSB), anatomic single bundle (ASB), and anatomic double bundle (ADB)—have been described.Purpose: To determine if double-bundle reconstruction is needed to restore rotational stability or if anatomic placement of a single bundle can yield similar results.Study Design: Randomized controlled trial; Level of evidence, 1.Methods: From December 2005 to December 2007, 320 patients were prospectively randomized into 3 groups: ADB, ASB, and CSB reconstruction. The average follow-up was 51.15 months (range, 39-63 months). At the final follow-up, 281 patients were available. In all groups, hamstring tendons were used with suspensory fixation on the femoral side and bioabsorbable interference screw fixation on the tibial side. The outcomes were evaluated by an independent blinded observer using the Lysholm score and subjective International Knee Documentation Committee (IKDC) form. The ...

Prospective Randomized Clinical Evaluation of Conventional Single-Bundle, Anatomic Single-Bundle, and Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: 281 Cases With 3- to 5-Year Follow-up

Purpose The primary aim was to summarize and assess current evidence from randomized controlled trials (RCTs) on anterior cruciate ligament injuries, with special reference to graft type and surgical technique. The secondary aims were to identify the relative strengths and weaknesses of the selected studies, to resolve contradictions in the literature, and to evaluate the need for further studies. Methods A PubMed database search using the key words "anterior cruciate ligament" was performed. The search was limited to RCTs published in English between January 1995 and March 2009. Articles on the subject of graft type and surgical technique were identified. After initial screening and a subsequent quality appraisal based on the CONSORT (Consolidated Standards of Reporting Trials) Statement, a total of 39 articles were included in this review. Results There are no differences between the bone–patellar tendon–bone (BPTB) graft and the hamstring tendon (HT) graft in terms of laxity, clinical outcome, time to return to sports, patellofemoral crepitations, 1-leg hop test, range of motion, thigh muscle circumference, or anterior knee sensory deficit. The BPTB graft produces more anterior knee pain and kneeling pain than the HT graft, but the difference disappears with time. The harvest site affects muscle strength initially but not over time. There is a possible correlation between the development of osteoarthritis and the BPTB graft. The HT graft produces more tunnel widening than the BPTB graft, but there is no correlation between tunnel widening and clinical outcome or laxity. The semitendinosus and gracilis graft is associated with inferior knee flexion at higher angles, as compared with the semitendinosus graft. There are probably no differences between the BPTB graft and the bone-HT-bone graft in terms of laxity and clinical outcome. Semitendinosus and gracilis tendon harvesting probably reduces hamstring muscle strength for approximately 1 year. Double-bundle reconstruction produces less rotatory laxity than single-bundle reconstruction. Double-bundle reconstruction by use of an 8-strand HT graft probably produces less laxity than single-bundle reconstruction. There are no differences in clinical outcome when single-bundle and double-bundle anterior cruciate ligament reconstructions are compared. Conclusions In the quality assessment several weaknesses in the study design of the RCTs were found. This emphasizes the need for further high-quality studies, especially with long-term follow-up. Level of Evidence Level II, systematic review of randomized controlled trials.

Treatment of Anterior Cruciate Ligament Injuries With Special Reference to Graft Type and Surgical Technique: An Assessment of Randomized Controlled Trials

To identify and evaluate the evidence for the pivot shift test as an outcome measure following ACL reconstruction. Achieving rotatory control of the knee post anterior cruciate ligament (ACL) reconstruction has been shown to increase patient satisfaction, decrease functional instability and potentially delay the development of osteoarthritis. The pivot shift is able to assess this rotatory component of knee laxity and appears to have the potential to become a benchmark in gauging the success of ACL surgery. Multiple confounding factors and discrepancies in performing the maneuver itself however put its usefulness in question. Thus, the literature was reviewed to assess whether the pivot shift was able to correlate with final functional outcomes. Two reviewers searched two databases (MEDLINE and EMBASE) for randomized control trials that involved anterior cruciate ligament reconstruction in the last 5 years. All non-clinical studies were excluded. A quality assessment of the included studies was performed using the Jadad scale by a reviewer. The number of studies using the Pivot Shift Test as well as the test’s relationship with functional outcome was evaluated. The literature search yielded 274 studies, of which 65 papers were included. The average Jadad quality score for papers reporting pivot shift as an outcome measure was 2.4, with the most frequent score being 3. Forty seven of 65 studies described the Pivot Shift Test as an outcome measure following ACL reconstruction. Of the 47 studies that included pivot shift as an outcome measure, 40 (85%) correlated with the final functional outcomes. The pivot shift test is an important test following ACL reconstruction, and it correlates with functional outcomes.

Pivot shift as an outcome measure for ACL reconstruction: a systematic review

Background: Arthroscopic meniscal repair techniques are continuing to evolve. Most studies to date comparing the healing rate of inside-out to all-inside meniscal repair techniques are confounded by associated anterior cruciate ligament reconstruction or deficiency.Purpose: This review was conducted to compare the effectiveness and complications of the inside-out repair technique to that of the all-inside repair technique in isolated unstable peripheral longitudinal (“bucket-handle”) meniscal tears.Study Design: Systematic review.Methods: Computerized keyword searches of MEDLINE, EMBASE, CINAHL, ACP Journal Club, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were performed. Two reviewers independently performed searches and article reduction. Studies that included stratified data for isolated unstable longitudinal meniscal tears in stable knees, repaired with either an inside-out or all-inside repair technique, were selected. Data on clinical failure, ...

Comparison of Inside-Out and All-Inside Techniques for the Repair of Isolated Meniscal Tears: A Systematic Review

Background:Conventional anterior cruciate ligament reconstruction techniques have focused on restoration of the anterome-dial bundle only, which, however, may be insufficient in restoring the rotational stability of the knee.Hypothesis:Rotational stability of the knee is better when using a double-bundle technique instead of a single-bundle technique for anterior cruciate ligament reconstruction.Study Design:Randomized controlled clinical trial; Level of evidence, 1.Methods:Seventy-seven patients were randomized into 3 different groups for anterior cruciate ligament reconstruction with hamstring tendons: double-bundle with bioabsorbable screw fixation (n = 25), single-bundle with bioabsorbable screw fixation (n = 27), and single-bundle with metallic screw fixation (n = 25). The evaluation methods were clinical examination, KT-1000 arthrometric measurement, and the International Knee Documentation Committee and Lysholm knee scores.Results:There were no differences between the study groups preoperatively. S...

Double-Bundle Anterior Cruciate Ligament Reconstruction Using Hamstring Autografts and Bioabsorbable Interference Screw Fixation Prospective, Randomized, Clinical Study With 2-Year Results

BackgroundAll-inside meniscal repairs have gained popularity in the past few years. However, only a few prospective, randomized clinical studies have been done to compare different all-inside meniscal repair techniques.HypothesisMeniscal repair with bioabsorbable meniscal screws and arrows results in similar clinical outcome on short-term follow-up.Study DesignRandomized controlled trial; Level of evidence, 2.MethodsForty-two patients were prospectively randomized to have all-inside meniscal repair either by using bioabsorbable meniscal screws or bioabsorbable meniscus arrows (21 patients, 23 meniscal repairs in each group) for the fixation. The evaluation methods were clinical examination, Lysholm score, the International Knee Documentation Committee (IKDC) knee score, and magnetic resonance arthrography (MRA) evaluation. The average follow-up time was 27 months (standard deviation, 8).ResultsThere were no differences between the study groups preoperatively. All 42 patients (100%) were available for the ...

All-Inside Meniscal Repair With Bioabsorbable Meniscal Screws or With Bioabsorbable Meniscus Arrows A Prospective, Randomized Clinical Study With 2-Year Results

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Double-Bundle Anterior Cruciate Ligament Reconstruction Using Hamstring Autografts and Bioabsorbable Interference Screw Fixation Prospective, Randomized, Clinical Study With 2-Year Results

All-Inside Meniscal Repair With Bioabsorbable Meniscal Screws or With Bioabsorbable Meniscus Arrows A Prospective, Randomized Clinical Study With 2-Year Results