SIMEG - sacroiliac medical expert group

Clinical Studies

Literature shows very few clinical SIJ fusion trials until 2012. There seems to be a lack of common sense within the medical community about the pain generator and appropriate therapies – particularly for preoperated and chronic  pain patients. Therefore a standardized study protocol has not yet be developed.

Randomized comparative studies of surgical methods are required. Premise: availability of a reference procedure. Medical device industry initiated some single-arm studies (single- or multicentered), and also some randomized studies have been started using non surgical therapies as a 2nd arm.

Discussion: Proposed study design

General
  • International prospective multicenter observation single arm study

Options (preferable):

  • 2 arms RCT surgical/non surgical or
  • 2 amrs RCT surgical method 1/ surgical method 2
  • Institutional review board declaration in accordance with professional ethics, Section 15 of the professional code of conduct and Section 23b of the German Medical Devices Act.
  • Register study centrally once (increases the impact of the publication)
Inclusion criteria
  • All consecutively recorded patients at a clinic with SI joint pathology which has failed to respond to conservative treatment for > 6 months
  • CT pathology not mandatory
  • Pain on palpation and at least 1 positive provocation test
  • >50% reduction in pain following SI joint or recess/lateral sacrum margin injection for more than 1 hour
Exclusion criteria
  • General/occupational disability pension, temporary disability benefits
  • Atypical pain diagram (more than 6 pain zones)
  • Concomitant lumbar or lumbosacral pathology or pathology of the hips must not be causing symptoms; exclusion using facet injections and epidural injections or PRT or hip joint injections respectively
  • Tumors in the bony pelvis
  • Bacterial inflammations in the bony pelvis
  • Fresh fractures of the pelvis Sacral insufficiency fractures
  • Bony defect situations near the SI joint or recess
  • More than one previous operation on the SI joint
Indications
  • Patients must have undergone at least 6 months of conservative treatment and must also have worn a corset for 4 weeks in cases of primarily ligament insufficiency (e.g. Sakro-Loc/Bauerfeind)
  • Previous facet injections L4/5 and L5/S1 with imaging (X-ray, CT) documented
  • Two infiltrations of the recess as well as the lateral sacral margin with crystalline corticosteroid and local anesthetic using imaging (X-ray, CT) documented
  • Two infiltrations of the joint with X-ray or CT monitoring using contrast agent as well as Triam or Volon 40/bupivacaine, verified with print-outs or DICOM files
  • Patients must respond with a significant pain reduction of >50% to either the infiltration of the recess or lateral sacrum margin or to injection of the joint; two groups may possibly be resolved here depending on the response to the different injection sites
  • Provocation test: Patrick-FABER test, compression or distraction test, thigh thrust, sacral thrust, Gaenslen test
  • All tests are carried out and the result documented; at least one of the provocation tests must be positive
  • Pain on palpation above the sacroiliac ligament positive
  • Sitting intolerance positive or negative
Laboratory diagnostics
  • Vitamin D3
  • Calcium
  • Phosphate
  • In case of vitamin D deficiency, administer 400,000 to 800,000 IU preoperatively to fill stores
  • If Ca preparations are used, then use Ca gluconate; concurrent Ca intake is necessary when taking proton pump inhibitors
Imaging
  • MRI of the lumbar spine preoperatively or CT in case of claustrophobia or pacemaker P
  • elvis overview pre/post/12 months
  • CT pre/post/12 months in 1.5 mm or 1.0 mm slices from L4 -> acetabulum
  • In case of suspected failed fusion, carry out CT checks early at 9 months postoperatively
Postoperative treatment
  • Sufficient analgesia No NSARs!!! (risk of delayed bone healing)
  • Dekristol (20,000 IU) 1x weekly for 6 months
  • Explain arthrodesis to patients
  • Explanation about the negative effects of smoking on the outcome of the surgery
  • Gait training (no additional physiotherapy, no rehabilitation for at least 3 months post-op!!!)
  • Toe-touch weight bearing (instead of 20 kg) with forearm crutches for 6 weeks or longer if necessary + heparinization, slow transition to full weight bearing
Scores

The questionnaires of standard scores need to be adapted to SIJ specifications:

  • ODI
  • McGill
  • SF12
  • MVAS
  • Roland-Morris
  • patient satisfaction
  • depression status
  • individual score (NEW: "That's MY problem")
  • pain diagram

Above proposals can be discussed in the conception of clinical trials for sij fusion. Supplemental concepts for non surgical comparative studies must be worked out as well.