The Clinical Standards of Practice (CSOP) consensus conference concept has been promoted and used by various professionals in the medical community to bring forth concepts of practice that are either poorly reported or under-reported in the literature. The postoperative care of the lower limb amputee is one such area. Although amputations have been performed for centuries as a lifesaving procedure, the current protocols for care of the person undergoing this life-altering surgical procedure, in some cases, may not reflect the complete and active lifestyle in which the amputee can now engage. Therefore, amputation must be viewed as a reconstructive procedure, and the postoperative protocol must be designed to enhance the functional potential of persons forced to undergo this physically and emotionally difficult surgery.
The CSOP on Postoperative Management of the Lower Extremity was funded by the American Academy of Orthotists and Prosthetists with donations to the Academy’s Project Quantum Leap. The 2-day conference convened May 31, 2003, co-chaired by Douglas G. Smith, MD, and Gary M. Berke, MS, CP. Participants were selected from a national pool of noted experts in the area of surgery and rehabilitation for the amputee. This multidisciplinary group was chosen specifically based on the participants’ years of experience and provision of literature in their areas of expertise. Disciplines included orthopaedic surgeons, vascular surgeons, physiatrists, prosthetists, physical therapists, and peer counselors.
The conference was an intense 2-day event that confirmed the exceptional level of knowledge of the participants and their dedication to providing the best care possible. Although the participants came from various regions of the country, and disagreements on appropriate treatment methods occurred, the recurrent theme was how to provide the best possible care for the amputee. In the end, we reached agreement or “agreed to disagree,” but in either case, we composed research questions that need to be answered if the truth about amputee rehabilitation is to be resolved so that the most effective course of treatment may be determined. Throughout this document, the amputated limb will be referred to as the “residual limb” or the “amputated limb,” despite that the International Standards Organization in Orthotics and Prosthetics has formally adopted the term “stump” as the appropriate term for the amputated limb. The authors of this document believe that this term may be offensive to some and therefore have elected to use the alternative terms.
A special thanks to Mr. Donald E. Katz, CO, LO, FAAOP, for his assistance in the formulation of this CSOP, for without his vision and guidance, this conference would not have been possible.
It is our hope that this document will be used and challenged by the medical community and that treatments in the future will improve as a result of our discussions.
Participants for this conference included representatives from various disciplines and subspecialties so that the recommendations from the committee would be related to all age groups, etiologies, and comorbidities. Five postoperative care strategies previously identified in the literature were adopted for discussion by the committee. These strategies include soft dressings; nonremovable rigid dressings without an immediate prosthetic attachment; nonremovable rigid dressings with an immediate postoperative prosthesis; removable rigid plaster dressings; and prefabricated postoperative prosthetic systems. Although the committee would have preferred to have spent a majority of time documenting a consensus on protocol associated with the particular strategies, the literature and evidence to date are primarily anecdotal and insufficient to support many of the claims made. Based on the literature review and the expert opinions presented, the conference participants agreed that it is currently not possible to provide evidence-based protocols or make conclusive evidence-based recommendations for the use of one strategy over another.
The committee then defined the various aspects of care that should be considered during the postoperative rehabilitation protocol. These issues are directly related to improving mobility, enhancing healing, limb volume management, and improving outcomes. Each stage of care from the preoperative period to the late stages of postoperative rehabilitation is defined. Realizing that the goals of care change at each of the stages of rehabilitation, a table of clinical concerns and treatment goals was established by the committee. These clinical concerns and treatment goals may be used by clinicians for development of treatment protocol and guidelines within their communities.
It was noted by the committee that wound healing is an area of significant controversy and often the definition of “healed” and “healing” varies from study to study. This committee has defined categories of wound healing to aid the clinician and researcher in standardizing this often subjective area. Goals of care associated specifically with the amputation, such as pain management, fall prevention, and improved mobility, are discussed, as are goals associated with overall patient care, such as musculoskeletal reconditioning and cardiopulmonary training, contralateral lower limb preservation, emotional care, and minimizing systemic complications.
Finally, reporting standards for assessing outcomes and research recommendations are discussed to assist the future of research and allow this important topic area to be reevaluated in a more comprehensive manner in the future.
Douglas G. Smith, MD, Associate Professor of Orthopaedic Surgery, University of Washington; Medical Director, Amputee Coalition of America, Seattle, Washington.
Gary M. Berke, MS, CP, FAAOP, Private Practitioner, Redwood City, California; Adjunct Clinical Instructor, Orthopaedic Surgery, Stanford University, Palo Alto, California.
Ryan Blanck, CPO, Northwest Prosthetic and Orthotic Clinic, Seattle, Washington.
Christian Bianchi, MD, Assistant Professor of Surgery, Loma Linda University; Chief, Endovascular Surgery, Loma Linda VAMC, Loma Linda, California.
Mary Williams Clark, MD, Clinical Professor of Surgery [Orthopedics] & Pediatrics, Michigan State University, College of Human Medicine, Lansing, Michigan.
Jan P. Ertl, MD, Assistant Clinical Professor, Department of Orthopaedic Surgery, UC Davis, Sacramento California; Chief, Ortho Trauma and Amputation Services, KPMC, Sacramento, California.
Alberto Esquenazi, MD, Chair, Department of PM&R, Albert Einstein and Moss Rehab; Director, Amputee Rehabilitation Center, Moss Rehab, Philadelphia, Pennsylvania.
John Fergason, CPO, Director, Division of Prosthetics-Orthotics, Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.
Matthew D. Flynn, CP, FAAOP, Eastside Orthotics & Prosthetics Inc., New York Presbyterian Hospital, New York, New York.
Robert Gailey, PhD, PT, Assistant Professor, University of Miami School of Medicine, Department of Orthopaedics, Division of Physical Therapy, Miami, Florida.
Todd Kuiken, MD, PhD, Assistant Professor, Department of PM&R, Northwestern University, Rehabilitation Institute of Chicago, Chicago, Illinois.
Robert “Skip” Meier, MD, Director, Amputee Services of America, Thornton, Colorado.
Joseph A. Miller, MEd, CP, Prosthetist, Walter Reed Army Medical Center, Washington, DC.
Michael S. Pinzur, MD, Professor of Orthopaedic Surgery and Rehabilitation, Loyola University Medical Center, May-wood, Illinois.
Lew C. Schon, MD, Assistant Professor of Orthopaedic Surgery, Johns Hopkins University; Director, Foot and Ankle Fellowship, Department of Orthopaedics, Union Memorial Hospital, Baltimore, Maryland.
Donald G. Shurr, CPO, PT, American Prosthetics and Orthotics, University of Iowa Hospitals, Iowa City, Iowa.
Laura L. Willingham, Prosthetics Research Study, ACA Representative, Seattle, Washington.
Yeongchi Wu, MD, Prosthetist, Center for International Rehabilitation; Associate Professor, Department of PM&R, Northwestern University, Chicago, Illinois.
The committee thanks Mr. Stewart Weiner, CPO, and Ms. Renee Loth-Cali for their posteditorial comment and review, as well as Chellie Blondes, Diane Ragusa, Tom Gorski, and the staff at the American Academy of Orthotists and Prosthetists for their continued assistance in making this conference and document a reality.
An intense interest in postamputation management strategies, especially for lower limb amputees, existed during the 1960s through the 1990s. The literature published on various postoperative strategies remains mostly descriptive, despite this attention. Fortunately, we identified that an extensive “critical review” of the literature was under way and actually near completion by members of the Veterans Administration (VA) center for amputation and prosthetics and the Prosthetics Research Study in Seattle, Washington, as the planning for this conference began. The entire paper, recently published by the VA’s Journal of Rehabilitation, Research and Development is attached as Addendum 1, and the abstract is reprinted here:
Critical Review of Postoperative Dressing and Management Strategies for Transtibial Amputations. Douglas G. Smith, MD, Lynne V. McFarland, PhD, MS, Bruce J. Sangeorzan, MD, Gayle E. Reiber, PhD, MPH, and Joseph M. Czerniecki, MD
Postamputation management is an important determinant of recovery from amputation. However, consensus on the most effective postoperative management strategies for individuals undergoing transtibial amputation (TTA) is lacking. Dressings can include simple soft gauze dressings, thigh-high rigid cast dressings, shorter removable rigid dressings, and prefabricated pneumatic dressings. Postoperative prosthetic attachments can be added to all but simple soft dressings. These dressings address the need to cleanly cover a fresh surgical wound, but not all postoperative dressings are designed to facilitate the strategic goals of preventing knee contractures, reducing edema, protecting against external trauma, or facilitating early weight bearing. The type of dressing and management strategy often overlap and are certainly interrelated. Current protocols and decisions are based on local practice, skill, and intuition. The current available literature is challenging, and difficulties include variations in healing potential, in comorbidity, in surgical-level selection, in techniques and skill, in experience with postoperative strategies, and with poorly defined outcome criteria. This article reviews the published literature and compares measures of safety, efficacy, and clinical outcomes of the various techniques. Analysis of 10 controlled studies supported only 4 of the 14 claims cited in uncontrolled, descriptive studies.
The literature supports that rigid plaster cast dressings result in significantly accelerated rehabilitation times and significantly less edema compared with soft gauze dressings, and prefabricated pneumatic prostheses were found to be associated with significantly fewer postoperative complications and required fewer higher-level revisions compared with soft gauze dressings. No studies directly compared pneumatic prostheses with rigid dressings, and no reports compared all types of dressings within one study. In conclusion, the literature and evidence to date are primarily anecdotal and insufficient to support many of the claims. Future randomized trials on TTA dressing and management strategies are clearly needed to collect the evidence needed to best guide clinicians with the decision. (J Rehabil Res Dev 2003;40:213–224).
POSTOPERATIVE MANAGEMENT STRATEGIES
The participants of the conference agreed upon using five major categories for postoperative management strategies: soft gauze dressings, nonremovable rigid dressings without prosthetic attachment, nonremovable rigid dressings with immediate prosthetic attachment, removable rigid plaster dressings, and prefabricated postoperative devices. For the purposes of this document, the term “strategy” refers specifically to the postamputation dressing or device, and “protocol” is used to define how the dressing or postoperative device is actually prescribed and used. The committee quickly realized that agreed-upon protocols for these strategies simply do not exist. The same general strategy often is applied differently in different geographic regions and clinics. The literature does not consistently define protocols for different strategies. As a result, the group elected not to attempt to reach a consensus or define protocols for each strategy because of the lack of evidence that currently exists within the literature. The conference participants reiterated that within categories, there exists a wide range of devices, often designed for different goals. The presented strategies were defined as follows:
- Soft dressings. This category includes soft gauze used alone or used with an adjunctive mechanism to obtain compression of the limb as well as possible use of supplemental devices to address knee flexion contractures. Adjuncts include, but are not limited to, elastic “ACE-type” wraps, tubular compressive gauze, traditional shrinker socks, gel liners, Unna paste wraps, and other forms of soft compressive dressings. The use of soft gauze without some type of light or moderate compression, although practiced, is not recommended. Additional supplemental devices, such as simple knee immobilizers, hinged knee immobilizers, and low-temperature thermoplastic protective shells are often used to attempt to minimize contractures or protect the amputation site. Although frequently used in many inpatient care settings, these devices do not directly offer a mechanism to promote residual limb maturation, and there is currently little literature to document their effectiveness.
- Nonremovable rigid dressings without an immediate prosthetic attachment. For the transtibial amputee, this is a custom-molded thigh-high device (plaster, fiberglass or other material). For the transfemoral amputee, this may or may not include a preformed brim and may or may not include a soft or rigid spica component around the waist.
- Nonremovable rigid dressings with an immediate postoperative prosthesis (IPOP). For the transtibial amputee, this is the traditional thigh-level cast (plaster, fiberglass, or combination) with pylon and foot attachment. For the transfemoral amputee, this includes a cast (plaster, fiber-glass, or combination) with a proximal socket style brim and typically a soft or rigid spica component around the waist. A knee unit may or may not be included. 1,2
- Removable rigid plaster dressings. This category includes removable rigid dressing made of casting material (plaster, fiberglass, or combination). As originally described, 3,4 the removable rigid dressing can be used with or without a prosthetic attachment. This dressing option allows for easy access to inspect the incision or manage small wounds after amputation. Being removable, this type of device also facilitates the management of edema by introducing and familiarizing the patient with the use of stump socks.
- Prefabricated postoperative prosthetic systems. This category includes a wide range of prefabricated devices, designed for early management and early prosthetic fitting of the limb after surgery. These devices provide varying degrees of protection and contracture prevention and are designed for early weight bearing. These devices maintain some of the advantages of the removable rigid dressing in that they are easily removed and replaced for wound evaluation.
COMPARISON OF THE STRATEGIES
The literature review points out that scientific evidence to support the use of one particular strategy over another is lacking. Analysis of 10 controlled studies supported only 4 of the 14 claims cited in uncontrolled, descriptive studies.
The literature supports that:
- Nonremovable rigid dressings result in significantly accelerated rehabilitation times compared with soft gauze dressings.
- Nonremovable rigid dressings result in significantly less edema compared with soft gauze dressings.
- Prefabricated postoperative prosthetic systems were found to have significantly fewer postoperative complications compared with soft gauze dressings.
- Prefabricated postoperative prosthetic systems lead to fewer higher-level revisions compared with soft gauze dressings.
No studies directly compared prefabricated postoperative prosthetic systems with rigid dressings, and no reports compared all types of dressings within one study. In conclusion, the literature and evidence to date are primarily anecdotal and insufficient to support many of the claims made. Based on this review, and the different expert opinions presented, the conference participants agreed that it is currently not possible to provide evidence-based protocols or make conclusive evidence-based recommendations for the use of one strategy over another.