More Recent History of Rapid Adoption of New Technology in Sports Medicine: Intra-Articular Pain Pumps

Abstract

I read with great interest the recent article by Virk and Kocher.1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar This article was very informative about the Food and Drug Administration (FDA) process and outlined the quick adoption of new technology without sufficient study and the subsequent abandonment of 2 procedures: thermal capsulorrhaphy and Gore-Tex anterior cruciate ligament (ACL) grafts. These 2 procedures are largely of historical significance and serve to reinforce the importance of sufficient study before marketing and clinical implementation. I had hoped the authors would have included a much more recent example of this issue that is still ongoing: pain pumps with continuous intra-articular infusion of local anesthetics and post-arthroscopic glenohumeral chondrolysis (PAGCL).Similar to Virk and Kocher's account of the initial clinical results of Gore-Tex ACL grafts and thermal capsulorrhaphy,1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar several short-term clinical studies starting in 2000 showed that pain pumps were effective. However, several of the early studies did not place the pain pumps into the intra-articular space.2Mallon W.J. Thomas C.W. Patient-controlled lidocaine analgesia for acromioplasty surgery.J Shoulder Elbow Surg. 2000; 9: 85-88Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 3Savoie F.H. Field L.D. Jenkins R.N. Mallon W.J. Phelps II, R.A. The pain control infusion pump for postoperative pain control in shoulder surgery.Arthroscopy. 2000; 16: 339-342Abstract Full Text Full Text PDF PubMed Scopus (129) Google Scholar, 4Hoenecke Jr, H.R. Pulido P.A. Morris B.A. Fronek J. The efficacy of continuous bupivacaine infiltration following anterior cruciate ligament reconstruction.Arthroscopy. 2002; 18: 854-858Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar Furthermore, all of the early studies used low-flow pain pumps at a rate of 2 mL/h. The first clinical study with intra-articular pain pump placement was also performed with a 2-mL/h pump with only a 100-mL reservoir.5Barber F.A. Herbert M.A. The effectiveness of an anesthetic continuous-infusion device on postoperative pain control.Arthroscopy. 2002; 18: 76-81Abstract Full Text PDF PubMed Scopus (90) Google Scholar These efficacy studies of low-volume and low-flow pain pumps were mainly focused on extra-articular use in the knee and shoulder, with no published longer-term safety studies beyond 1 week.In vitro and animal model studies did not appear in the literature until 2006 when the studies of Chu et al.6Chu C.R. Izzo N.J. Papas N.E. Fu F.H. In vitro exposure to 0.5% bupivacaine is cytotoxic to bovine articular chondrocytes.Arthroscopy. 2006; 22: 693-699Abstract Full Text Full Text PDF PubMed Scopus (217) Google Scholar and Gomoll et al.7Gomoll A.H. Kang R.W. Williams J.M. Bach B.R. Cole B.J. Chondrolysis after continuous intra-articular bupivacaine infusion: An experimental model investigating chondrotoxicity in the rabbit shoulder.Arthroscopy. 2006; 22: 813-819Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar were published.8Karpie J.C. Chu C.R. Lidocaine exhibits dose- and time-dependent cytotoxic effects on bovine articular chondrocytes in vitro.Am J Sports Med. 2007; 35: 1621-1627Crossref PubMed Scopus (160) Google Scholar Both studies yielded concerning findings regarding cartilage toxicity with local anesthetic exposure. By 2007, Hansen et al.9Hansen B.P. Beck C.L. Beck E.P. Townsley R.W. Postarthroscopic glenohumeral chondrolysis.Am J Sports Med. 2007; 35: 1628-1634Crossref PubMed Scopus (162) Google Scholar were the first authors to recognize the association of intra-articular pain pumps and coined the term PAGCL.Unacceptable rates of PAGCL were published in numerous studies of the shoulder. A retrospective study showed that prevalence ranged up to 63%; in reviews of the literature, prevalence ranged up to 67%; and prevalence was up to 82% for PAGCL patient cohorts treated by use of intra-articular pain pumps with local anesthetics.9Hansen B.P. Beck C.L. Beck E.P. Townsley R.W. Postarthroscopic glenohumeral chondrolysis.Am J Sports Med. 2007; 35: 1628-1634Crossref PubMed Scopus (162) Google Scholar, 10Solomon D.J. Navaie M. Stedje-Larsen E.T. Smith J.C. Provencher M.T. Glenohumeral chondrolysis after arthroscopy: A systematic review of potential contributors and causal pathways.Arthroscopy. 2009; 25: 1329-1342Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar, 11Levy J.C. Virani N.A. Frankle M.A. et al.Young patients with shoulder chondrolysis following arthroscopic shoulder surgery treated with total shoulder arthroplasty.J Shoulder Elbow Surg. 2008; 17: 380-388Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar Despite these studies, pain pump use continued. The first reported case of chondrolysis with intra-articular pain pumps in the knee was not published until 2009.12Fester E.W. Noyes F.R. Postoperative chondrolysis of the knee: 3 case reports and a review of the literature.Am J Sports Med. 2009; 37: 1848-1854Crossref PubMed Scopus (22) Google ScholarVirk and Kocher1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar also commented on the FDA's classification of Gore-Tex ACL grafts and thermal capsulorrhaphy. The history of the FDA and intra-articular pain pumps is even more remarkable. The pain pumps' manufacturers were never granted FDA approval for intra-articular use of pain pumps with continuous delivery of local anesthetics. The companies marketed the pain pumps using terms such as “operative site” and “wound site” to avoid direct reference to intra-articular placement, with many of the ads placed in Arthroscopy dating back to 1999.According to the FDA: “Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. Neither local anesthetics nor infusion devices are approved for an indication of continuous intra-articular infusion. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.”13Food and Drug AdministrationInformation for healthcare professionals—Chondrolysis reported with continuously infused local anesthetics.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformaltionforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190302.htmGoogle ScholarFortunately, according to Virk and Kocher,1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar the Gore-Tex prosthetic ligaments were recalled by 1993 and the Editors of Arthroscopy recommended the end of clinical use of thermal capsulorrhaphy in 2007. Unfortunately, pain pumps are still available for orthopaedic use, although in the current literature, it is widely recommended that they not be used in the intra-articular space.The lack of published preclinical animal or in vitro safety testing, as well as early clinical studies that lacked any significant follow-up, undoubtedly contributed to this situation. The pain pumps were rushed to market before any appropriate testing was done. Furthermore, use rapidly evolved to high-flow and high-volume pain pumps placed in the intra-articular space from the initial clinical studies. Surgeons should ask company representatives marketing products about their FDA status and labeling. The misleading marketing and lack of FDA approval for pain pumps used in the joint space are also very concerning for our field.I applaud Virk and Kocher1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar for this article and for calling our attention to the importance of FDA approval, safety testing, and basic science research before adopting new technology. I hope to further bring attention to the dangers of intra-articular pain pump use with local anesthetics as a more current technology in use in sports medicine for which causation for PAGCL is being debated in the courtroom. Many patients with PAGCL are young and active and have had a life-altering complication. Chondrolysis is a much more devastating complication than failure of an ACL graft or capsulorrhaphy. I only hope the editors can similarly recommend ceasing use of pain pumps in orthopaedic surgery and that we can learn from these mistakes to be more cautious before adopting new technology. I read with great interest the recent article by Virk and Kocher.1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar This article was very informative about the Food and Drug Administration (FDA) process and outlined the quick adoption of new technology without sufficient study and the subsequent abandonment of 2 procedures: thermal capsulorrhaphy and Gore-Tex anterior cruciate ligament (ACL) grafts. These 2 procedures are largely of historical significance and serve to reinforce the importance of sufficient study before marketing and clinical implementation. I had hoped the authors would have included a much more recent example of this issue that is still ongoing: pain pumps with continuous intra-articular infusion of local anesthetics and post-arthroscopic glenohumeral chondrolysis (PAGCL). Similar to Virk and Kocher's account of the initial clinical results of Gore-Tex ACL grafts and thermal capsulorrhaphy,1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar several short-term clinical studies starting in 2000 showed that pain pumps were effective. However, several of the early studies did not place the pain pumps into the intra-articular space.2Mallon W.J. Thomas C.W. Patient-controlled lidocaine analgesia for acromioplasty surgery.J Shoulder Elbow Surg. 2000; 9: 85-88Abstract Full Text Full Text PDF PubMed Scopus (28) Google Scholar, 3Savoie F.H. Field L.D. Jenkins R.N. Mallon W.J. Phelps II, R.A. The pain control infusion pump for postoperative pain control in shoulder surgery.Arthroscopy. 2000; 16: 339-342Abstract Full Text Full Text PDF PubMed Scopus (129) Google Scholar, 4Hoenecke Jr, H.R. Pulido P.A. Morris B.A. Fronek J. The efficacy of continuous bupivacaine infiltration following anterior cruciate ligament reconstruction.Arthroscopy. 2002; 18: 854-858Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar Furthermore, all of the early studies used low-flow pain pumps at a rate of 2 mL/h. The first clinical study with intra-articular pain pump placement was also performed with a 2-mL/h pump with only a 100-mL reservoir.5Barber F.A. Herbert M.A. The effectiveness of an anesthetic continuous-infusion device on postoperative pain control.Arthroscopy. 2002; 18: 76-81Abstract Full Text PDF PubMed Scopus (90) Google Scholar These efficacy studies of low-volume and low-flow pain pumps were mainly focused on extra-articular use in the knee and shoulder, with no published longer-term safety studies beyond 1 week. In vitro and animal model studies did not appear in the literature until 2006 when the studies of Chu et al.6Chu C.R. Izzo N.J. Papas N.E. Fu F.H. In vitro exposure to 0.5% bupivacaine is cytotoxic to bovine articular chondrocytes.Arthroscopy. 2006; 22: 693-699Abstract Full Text Full Text PDF PubMed Scopus (217) Google Scholar and Gomoll et al.7Gomoll A.H. Kang R.W. Williams J.M. Bach B.R. Cole B.J. Chondrolysis after continuous intra-articular bupivacaine infusion: An experimental model investigating chondrotoxicity in the rabbit shoulder.Arthroscopy. 2006; 22: 813-819Abstract Full Text Full Text PDF PubMed Scopus (199) Google Scholar were published.8Karpie J.C. Chu C.R. Lidocaine exhibits dose- and time-dependent cytotoxic effects on bovine articular chondrocytes in vitro.Am J Sports Med. 2007; 35: 1621-1627Crossref PubMed Scopus (160) Google Scholar Both studies yielded concerning findings regarding cartilage toxicity with local anesthetic exposure. By 2007, Hansen et al.9Hansen B.P. Beck C.L. Beck E.P. Townsley R.W. Postarthroscopic glenohumeral chondrolysis.Am J Sports Med. 2007; 35: 1628-1634Crossref PubMed Scopus (162) Google Scholar were the first authors to recognize the association of intra-articular pain pumps and coined the term PAGCL. Unacceptable rates of PAGCL were published in numerous studies of the shoulder. A retrospective study showed that prevalence ranged up to 63%; in reviews of the literature, prevalence ranged up to 67%; and prevalence was up to 82% for PAGCL patient cohorts treated by use of intra-articular pain pumps with local anesthetics.9Hansen B.P. Beck C.L. Beck E.P. Townsley R.W. Postarthroscopic glenohumeral chondrolysis.Am J Sports Med. 2007; 35: 1628-1634Crossref PubMed Scopus (162) Google Scholar, 10Solomon D.J. Navaie M. Stedje-Larsen E.T. Smith J.C. Provencher M.T. Glenohumeral chondrolysis after arthroscopy: A systematic review of potential contributors and causal pathways.Arthroscopy. 2009; 25: 1329-1342Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar, 11Levy J.C. Virani N.A. Frankle M.A. et al.Young patients with shoulder chondrolysis following arthroscopic shoulder surgery treated with total shoulder arthroplasty.J Shoulder Elbow Surg. 2008; 17: 380-388Abstract Full Text Full Text PDF PubMed Scopus (71) Google Scholar Despite these studies, pain pump use continued. The first reported case of chondrolysis with intra-articular pain pumps in the knee was not published until 2009.12Fester E.W. Noyes F.R. Postoperative chondrolysis of the knee: 3 case reports and a review of the literature.Am J Sports Med. 2009; 37: 1848-1854Crossref PubMed Scopus (22) Google Scholar Virk and Kocher1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar also commented on the FDA's classification of Gore-Tex ACL grafts and thermal capsulorrhaphy. The history of the FDA and intra-articular pain pumps is even more remarkable. The pain pumps' manufacturers were never granted FDA approval for intra-articular use of pain pumps with continuous delivery of local anesthetics. The companies marketed the pain pumps using terms such as “operative site” and “wound site” to avoid direct reference to intra-articular placement, with many of the ads placed in Arthroscopy dating back to 1999. According to the FDA: “Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. Neither local anesthetics nor infusion devices are approved for an indication of continuous intra-articular infusion. Health care professionals are encouraged to follow the instructions for use of elastomeric infusion devices, and to not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery.”13Food and Drug AdministrationInformation for healthcare professionals—Chondrolysis reported with continuously infused local anesthetics.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformaltionforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190302.htmGoogle Scholar Fortunately, according to Virk and Kocher,1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar the Gore-Tex prosthetic ligaments were recalled by 1993 and the Editors of Arthroscopy recommended the end of clinical use of thermal capsulorrhaphy in 2007. Unfortunately, pain pumps are still available for orthopaedic use, although in the current literature, it is widely recommended that they not be used in the intra-articular space. The lack of published preclinical animal or in vitro safety testing, as well as early clinical studies that lacked any significant follow-up, undoubtedly contributed to this situation. The pain pumps were rushed to market before any appropriate testing was done. Furthermore, use rapidly evolved to high-flow and high-volume pain pumps placed in the intra-articular space from the initial clinical studies. Surgeons should ask company representatives marketing products about their FDA status and labeling. The misleading marketing and lack of FDA approval for pain pumps used in the joint space are also very concerning for our field. I applaud Virk and Kocher1Virks S.S. Kocher M.S. Adoption of new technology in sports medicine: Case studies of the Gore-Tex prosthetic ligament and of thermal capsulorrhaphy.Arthroscopy. 2011; 27: 113-121Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar for this article and for calling our attention to the importance of FDA approval, safety testing, and basic science research before adopting new technology. I hope to further bring attention to the dangers of intra-articular pain pump use with local anesthetics as a more current technology in use in sports medicine for which causation for PAGCL is being debated in the courtroom. Many patients with PAGCL are young and active and have had a life-altering complication. Chondrolysis is a much more devastating complication than failure of an ACL graft or capsulorrhaphy. I only hope the editors can similarly recommend ceasing use of pain pumps in orthopaedic surgery and that we can learn from these mistakes to be more cautious before adopting new technology. Adoption of New Technology in Sports Medicine: Case Studies of the Gore-Tex Prosthetic Ligament and of Thermal CapsulorrhaphyArthroscopyVol. 27Issue 1PreviewEvaluation of new technology in sports medicine is supposed to promote improvements in the care of patients. It is also supposed to prohibit technology that can harm patients. This evaluation process is not perfect and at times can promote technology that not only does not help patients but may harm them. Two examples of new sports medicine technology that were widely adopted but eventually abandoned are thermal capsulorrhaphy for treatment of shoulder instability and the Gore-Tex prosthetic ligament (W. Full-Text PDF Author's ReplyArthroscopyVol. 27Issue 4PreviewWe thank Dr. Busfield for his interest in our article about the adoption of new technology in sports medicine. We also appreciate his comments regarding the current issues surrounding the use of intra-articular continuous infusion of local anesthetic and post-arthroscopic glenohumeral chondrolysis. Full-Text PDF