This is the current release of the guideline.

Symptomatic osteoporotic spinal compression fractures

Adults (defined as patients 18 years of age and older) with symptomatic osteoporotic spinal compression fractures

Study Selection Criteria

The work group developed a priori article inclusion criteria for our review. These criteria are the "rules of evidence" and articles that do not meet them are, for the purposes of this guideline, not evidence.

To be included in the systematic reviews (and hence, in this guideline) an article had to be a report of a study that:

• Investigates osteoporotic spinal compression fracture patients
• Is a full article report of a clinical study (i.e., retrospective case series, medical records review, meeting abstracts, historical articles, editorials, letters, and commentaries are excluded)
• Was published in English
• Was published in or after 1966
• Appeared in a peer-reviewed publication
• Enrolled 10 or more patients per group
• Presented results quantitatively
• Enrolled patients 18 years of age or older (100% of study population)
• Is not an in vitro, biomechanical, or cadaver study
• Excluded the following patients (unless results were reported separately):
  Osteogenesis imperfecta (OI)
  Solid metastatic tumors of the spine
• For any given follow-up time point in any included study, there must be ≥50% patient follow-up (if the follow-up is >50% but <80%, the study quality will be downgraded by one level)
• Results reported as "post-hoc subgroup analyses" will be excluded

When a study's "duration of symptoms" is not the same as those examined by the work group (i.e., 0-2 weeks, 2-6 weeks, etc.) the study will be assigned to the appropriate "duration of symptoms" group based upon the mean duration of symptoms. If a range rather than mean is provided, the higher end of the range will dictate which "duration of symptoms" group the study will be assigned to. For example, a study reporting patient symptoms of 0-4 weeks would be included in the time frame "2-6 weeks" created by the work group.

When considering studies for inclusion, the work group included only the best available evidence. Accordingly, they first included Level I evidence. In the absence of two or more studies of this Level, they sequentially searched for and included Level II through Level IV evidence, and did not proceed to a lower level if there were two or more studies of a higher level. For example, if there were two Level II studies that addressed a recommendation, they did not include Level III or IV studies.

Literature Searches

The work group attempted to make the searches for articles comprehensive. Using comprehensive literature searches ensures that the evidence they considered for this guideline is not biased for (or against) any particular point of view.

The work group searched for articles published from January 1966 to December 31, 2009. They searched four electronic databases: PubMed, EMBASE, CINAHL, and The Cochrane Central Register of Controlled Trials. Strategies for searching electronic databases were constructed by a medical librarian using previously published search strategies to identify relevant studies.

They supplemented searches of electronic databases with manual screening of the bibliographies of all retrieved publications. They also searched the bibliographies of recent systematic reviews and other review articles for potentially relevant citations. Finally, work group members provided a list of potentially relevant studies that were not identified by the searches. All articles identified were subject to the study selection criteria listed above.

The study attrition diagram in Appendix III in the original guideline document provides details about the inclusion and exclusion of the studies considered for this guideline. The search strategies used to identify these studies are provided in Appendix IV in the original guideline document.

50 articles were included.

Levels of Evidence for Primary Research Question¹

¹ A complete assessment of quality of individual studies requires critical appraisal of all aspects of the study design.
² A combination of results from two or more prior studies.
³ Studies provided consistent results.
⁴ Study was started before the first patient enrolled.
⁵ Patients treated one way (e.g., cemented hip arthroplasty) compared with a group of patients treated in another way (e.g., uncemented hip arthroplasty) at the same institution.
⁶ The study was started after the first patient enrolled.
⁷ Patients identified for the study based on their outcome, called "cases"; e.g., failed total hip arthroplasty, are compared to those who did not have outcome, called "controls"; e.g., successful total hip arthroplasty.
⁸ Patients treated one way with no comparison group of patients treated in another way.

Data Extraction

Data elements extracted from studies were defined in consultation with the physician work group. The elements extracted are shown in Appendix V in the original guideline document. Evidence tables were constructed to summarize the best evidence pertaining to each preliminary recommendation. Disagreements about the accuracy of extracted data were resolved by consensus and consulting the work group.

Judging the Quality of Evidence

Determining the quality of the included evidence is vitally important when preparing any evidence-based work product. Doing so conveys the amount of confidence one can have in any study's results. One has more confidence in high quality evidence than in low quality evidence.

Assigning a level of evidence on the basis of study design plus other quality characteristics ties the levels of evidence the work group reports more closely to quality than levels of evidence based only on study design. Because the work group ties quality to levels of evidence, they are able to characterize the confidence one can have in their results. Accordingly, they characterize the confidence one can have in Level I evidence as high, the confidence one can have in Level II and III evidence as moderate, and the confidence one can have in Level IV and V evidence as low. Similarly, throughout the guideline they refer to Level I evidence as reliable, Level II and III evidence as moderately reliable, and Level IV and V evidence as not reliable.

Statistical Methods

When possible the results of statistical analysis conducted by the American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guidelines Unit using STATA 10.0 (StataCorp LP, College Station, Texas) are reported. The program was used to determine the magnitude of the treatment effect. For data reported as means (and associated measures of dispersion) the mean difference between groups was calculated. For proportions, the odds ratio was calculated as a measure of treatment effect. When no events occur ("zero event") in a proportion, the variance of the arcsine difference was used to determine statistical significance (p < 0.05).

To compare recurrent and adjacent fracture rates the work group reports the proportion of patients that experienced a fracture and percentage of patients that experienced a fracture. The variance of the arcsine difference was used to determine statistical significance (p < 0.05) of fracture rates.

The work group performed meta-analyses using the random effects method of DerSimonian and Laird. Heterogeneity was assessed with the I-squared statistic. All meta-analyses were performed using STATA 10.0 (StataCorp LP, College Station, Texas) and the "metan" command.

To assess the power of an outcome to detect a statistically significant difference the work group determined whether the number of patients in the study was sufficient to detect a small, medium, or large effect, while assuming an alpha of 0.05 as the significance level, 80% power, and Cohen's definitions of small, medium, and large effects (a small effect is d = 0.2, a medium effect is d = 0.5, and a large effect is d = 0.8). When a study with a nonsignificant difference that was unable to detect a large effect it was categorized as low power. Studies able to detect medium effects or with statistically significant differences were categorized as high power.

When published studies report measures of dispersion other than the standard deviation the value was estimated to facilitate calculation of the treatment effect. In studies that report standard errors or confidence intervals the standard deviation was back-calculated. In studies that only report the median, range, and size of the trial, they estimated the means and variances according to a published method. Studies that report results in graphical form were analyzed with TechDig 2.0 (Ronald B. Jones, Mundelein, Illinois) to estimate the mean and variance.

In some circumstances statistical testing was conducted by the authors and measures of dispersion were not reported. In the absence of measures of dispersion, the results of the statistical analyses conducted by the authors are included in the analysis and are identified as those of the study authors.

This guideline and systematic review were prepared by the American Academy of Orthopaedic Surgeons (AAOS) Treatment of Symptomatic Osteoporotic Spinal Compression Fractures guideline work group with the assistance of the AAOS Clinical Practice Guidelines Unit in the Department of Research and Scientific Affairs at the AAOS (see Appendix I in the original guideline document).

To develop this guideline, the work group held an introductory meeting to develop the scope of the guideline on March 28, 2009. Upon completion of the systematic review, the work group met again on February 27 and 28, 2010 to write and vote on the final recommendations and rationales for each recommendation.

Formulating Preliminary Recommendations

The work group began work on this guideline by constructing a set of preliminary recommendations. These recommendations specify [what] should be done in [whom], [when], [where], and [how often or how long]. They function as questions for the systematic review, not as final recommendations or conclusions. Preliminary recommendations are almost always modified on the basis of the results of the systematic review. Once established, these a priori preliminary recommendations cannot be modified until the final work group meeting, they must be addressed by the systematic review, and the relevant review results must be presented in the final guideline.

Defining the Strength of the Recommendations

To develop the strength of a recommendation, AAOS staff first assigned a preliminary strength for each recommendation that took only the quality and quantity of the available evidence into account (see "Rating Scheme for the Strength of the Recommendations" field). Work group members then modified the preliminary strength using the "Form for Assigning Strength of Recommendation (Interventions)" shown in Appendix VII in the original guideline document.

Consensus Development

The recommendations and their strength were voted on using a structured voting technique known as the nominal group technique. The work group presents details of this technique in Appendix VIII in the original guideline document. Voting on guideline recommendations was conducted using a secret ballot and work group members were blinded to the responses of other members. If disagreement between work group members was significant, there was further discussion to see whether the disagreement(s) could be resolved. Up to three rounds of voting were held to attempt to resolve disagreements. If disagreements were not resolved following three voting rounds, no recommendation was adopted. Lack of agreement is a reason that the strength for some recommendations is labeled "Inconclusive."

Strength of Recommendation

American Academy of Orthopaedic Surgeons Guideline Language

A formal cost analysis was not performed and published cost analyses were not reviewed.

Peer Review

The draft of the guideline and evidence report was peer reviewed by an external, outside specialty panel that was nominated a priori by the physician work group prior to the development of the guideline. The physician members of the American Academy of Orthopaedic Surgeons (AAOS) Guidelines and Technology Oversight Committee and the Evidence Based Practice Committee also provided peer review of the draft document. Peer review was accomplished using a structured peer review form (see Appendix IX in the original guideline document). The draft guideline was sent to a total of 32 reviewers and 11 returned reviews (see Appendix X in the original guideline document). The disposition of all non-editorial peer review comments was documented and accompanied this guideline through the public commentary and the AAOS guideline approval process.

Public Commentary

After modifying the draft in response to peer review, the guideline was subjected to a thirty day period of "Public Commentary." Commentators consist of members of the AAOS Board of Directors (BOD), members of the Council on Research, Quality Assessment, and Technology (CORQAT), members of the Board of Councilors (BOC), and members of the Board of Specialty Societies (BOS). Based on these bodies, over 200 commentators had the opportunity to provide input into this guideline development process. Of these, forty-nine members received the document for review and one member returned public comments (see Appendix X in the original guideline document).

The AAOS Guideline Approval Process

Following public commentary, the draft was again modified by the AAOS Clinical Practice Guidelines Unit and work group members. This final guideline draft was approved by the AAOS Guidelines Oversight Committee, the AAOS Evidence Based Practice Committee, the AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors. Descriptions of these bodies are provided in Appendix II in the original guideline document.

Definitions of the strength of recommendations (Strong, Moderate, Weak, Inconclusive, and Consensus) are provided at the end of the "Major Recommendations" field.

Note from the American Academy of Orthopaedic Surgeons (AAOS): This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report (see "Guideline Availability" and "Availability of Companion Documents" fields) for this information. The work group is confident that those who read the full guideline and evidence report will see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility.

1. The work group suggests that patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms suggesting an acute injury (0-5 days after identifiable event or onset of symptoms) and who are neurologically intact be treated with calcitonin for 4 weeks.

   Strength of Recommendation: Moderate

2. Ibandronate and strontium ranelate are options to prevent additional symptomatic fractures in patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms.

   Strength of Recommendation: Weak

3. The work group is unable to recommend for or against bed rest, complementary and alternative medicine, or opioids/analgesics for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Inconclusive

4. It is an option to treat patients who present with an osteoporotic spinal compression fracture at L3 or L4 on imaging with correlating clinical signs and symptoms suggesting an acute injury and who are neurologically intact with an L2 nerve root block.

   Strength of Recommendation: Weak

5. The work group is unable to recommend for or against treatment with a brace for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Inconclusive

6. The work group is unable to recommend for or against a supervised or unsupervised exercise program for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Inconclusive

7. The work group is unable to recommend for or against electrical stimulation for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Inconclusive

8. The work group recommends against vertebroplasty for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Strong

9. Kyphoplasty is an option for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are neurologically intact.

   Strength of Recommendation: Weak

10. The work group is unable to recommend for or against improvement of kyphosis angle in the treatment of patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms.

    Strength of Recommendation: Inconclusive

11. The work group is unable to recommend for or against any specific treatment for patients who present with an osteoporotic spinal compression fracture on imaging with correlating clinical signs and symptoms and who are not neurologically intact.

    Strength of Recommendation: Inconclusive

Definitions:

Levels of Evidence: See the "Rating Scheme for the Strength of the Evidence" field.

Strength of Recommendation

American Academy of Orthopaedic Surgeons Guideline Language

None provided

The type of supporting evidence is specifically stated for each recommendation (see the "Major Recommendations" field).

The aim of treatment is pain relief and recovery of mobility.

Contraindications vary widely based on the treatment administered. Therefore, discussion of available treatments and procedures applicable to the individual patient rely on mutual communication between the patient and physician, weighing the potential risks and benefits for that patient.

The primary purpose of the present document is to provide interested readers with full documentation about not only the recommendations, but also about how the work group arrived at those recommendations. This document is also posted on the American Academy of Orthopaedic Surgeons (AAOS) website at http://www.aaos.org/research/guidelines/guide.asp .

Shorter versions of the guideline are available in other venues. Publication of most guidelines is announced by an Academy press release, articles authored by the work group and published in the Journal of the American Academy of Orthopaedic Surgeons, and articles published in AAOS Now. Most guidelines are also distributed at the AAOS Annual Meeting in various venues such as on Academy Row and at Committee Scientific Exhibits.

Selected guidelines are disseminated by webinar, an Online Module for the Orthopaedic Knowledge Online website, Radio Media Tours, Media Briefings, and by distributing them at relevant Continuing Medical Education (CME) courses and at the AAOS Resource Center.

Other dissemination efforts outside of the AAOS will include submitting the guideline to the National Guideline Clearinghouse and distributing the guideline at other medical specialty societies' meetings.

Not applicable: The guideline was not adapted from another source.

American Academy of Orthopaedic Surgeons

This guideline and systematic review were prepared by the American Academy of Orthopaedic Surgeons (AAOS) Treatment of Symptomatic Osteoporotic Spinal Compression Fractures guideline work group with the assistance of the AAOS Clinical Practice Guidelines Unit in the Department of Research and Scientific Affairs at the AAOS.

Work Group: Stephen I Esses, MD, Chair, Southwest Orthopedic Group; Robert McGuire, MD, Vice-Chair, University of Mississippi Medical Center, Department of Orthopedic Surgery; John Jenkins, MD, University of Mississippi Medical Center, Division of Rheumatology, Department of Medicine; Joel Finkelstein, MD; Eric Woodard, MD, New England Baptist Hospital

Guidelines and Technology Oversight Chair: William C. Watters III, MD

Guidelines and Technology Oversight Vice-Chair: Michael J. Goldberg, MD, Department of Orthopaedics, Seattle Children's Hospital

Evidence Based Practice Committee Chair: Michael Keith, MD

American Academy of Orthopaedic Surgeons (AAOS) Staff: Charles M. Turkelson, PhD, Director of Research and Scientific Affairs; Janet L. Wies, MPH, AAOS Clinical Practice Guideline Manager; Patrick Sluka, MPH, AAOS Research Analyst; Kevin M. Boyer, AAOS Research Analyst; Kristin Hitchcock, MLS, AAOS Medical Librarian

Special Acknowledgements: Sara Anderson, MPH; Laura Raymond, MA

All members of the American Academy of Orthopaedic Surgeons (AAOS) work group disclosed any conflicts of interest prior to the development of the recommendations for this guideline. Conflicts of interest are disclosed in writing with the American Academy of Orthopaedic Surgeons via a private on-line reporting database and also verbally at the recommendation approval meeting.

Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts. 1 = Board member/owner/officer/committee appointments; 2 = Medical/orthopaedic publications; 3 = Royalties; 4 = Speakers bureau/paid presentations; 5A = Paid consultant; 5B = Unpaid consultant; 6 = Research or institutional support from a publisher; 7 = Research or institutional support from a company or supplier; 8 = Stock or stock options; 9 = Other financial/material support from a publisher; 10 = Other financial/material support from a company or supplier.

Stephen I Esses, MD (Houston, TX): 2 (Orthopedics; Spine; THE SPINE JOURNAL). Submitted on: 10/23/2009 and last confirmed as accurate on 01/22/2010.

Joel A Finkelstein, MD (Toronto, ON, Canada): 7 (Stryker; Synthes). Submitted on: 02/03/2009.

John Jenkins (Jackson, MS): 4 (Norvartis; Procter & Gamble; Roche). Submitted on: 03/11/2009.

Robert A McGuire, Jr MD (Jackson, MS): 1 (AOSpine North America chairman); 2 (Journal of Spinal Disorders); 3 (DePuy, A Johnson & Johnson Company); 5A (Synthes); 7 (AO; Stryker). Submitted on: 02/16/2009.

Eric John Woodard, MD (Boston, MA): 1 (AOSpine); 4 (DePuy, A Johnson & Johnson Company; Stryker; Synthes); 5A (invivo therapeutics); 7 (Synthes; AOSpine); 8 (Medtronic); 10 (Nanoventures). Submitted on: 03/24/2009.

William Charles Watters III, MD (Houston, TX): 1 (North American Spine Society; American Board of Spine Surgery; Board of Adviser Official Disability Guidelines; Associate Member of The Editorial Board, The Spine Journal; Med Center Ambulatory Surgery Center); 2 (The Spine Journal); 4 (Stryker; Synthes); 5A (Orthofix, Inc.; Stryker); 8 (Intrinsic Therapeutics). Submitted on: 08/14/2009.

This is the current release of the guideline.

Electronic copies: Available from the American Academy of Orthopaedic Surgeons Web site .

Print copies: Available from the American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018-4262. Telephone: (800) 626-6726 (800 346-AAOS); Fax: (847) 823-8125; Web site: www.aaos.org .

The following is available:

• American Academy of Orthopaedic Surgeons (AAOS) Guideline on the treatment of osteoporotic spinal compression fractures. Summary of recommendations. Rosemont (IL): American Academy of Orthopaedic Surgeons; 2010 Sep. 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American Academy of Orthopaedic Surgeons (AAOS) Web site .

Print copies: Available from the American Academy of Orthopaedic Surgeons, 6300 North River Road, Rosemont, IL 60018-4262. Telephone: (800) 626-6726 (800 346-AAOS); Fax: (847) 823-8125; Web site: www.aaos.org .

The following is available:

• Osteoporosis and spinal fractures. Rosemont (IL): American Academy of Orthopaedic Surgeons; 2010 May. Available from the American Academy of Orthopaedic Surgeons Web site .

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

This NGC summary was completed by ECRI Institute on April 21, 2011.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. For more information, please contact AAOS Department of Research and Scientific Affairs, 6300 North River Road, Rosemont, IL 60018; Phone: (847) 823-7186; Fax: (847) 823-8125.