Comparing current treatments for children with Legg-Calvé-Perthes disease, a hip disorder

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teens with Legg-Calvé-Perthes disease, a childhood hip disorder. It follows the results of the usual treatments chosen by their doctors.

Age

1 to 18 years

Sex

All sexes

Disease stage

Diagnosed with Legg-Calvé-Perthes disease. People over age 11 with possible bone death in the thigh bone head (femoral osteonecrosis) caused by injury or corticosteroid therapy can also join.

Earlier treatment

No previous surgery on the affected hip.

Main reasons for not taking part

• Previous surgery on the affected hip

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 1 and 18 years old?YesNo

What the trial wants to find out

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments.

The 12 groups in the trial

• Nonoperative management between ages 6-8 in early stage

  The choice of non-osteotomy management without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Nonoperative Observation

• Operative management between age 6-8 in early stage

  Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) rendered in the early stage of the disease process

  Treatment: Osteotomy + Long Term Non-Weight Bearing and Osteotomy + Short Term Non-Weight Bearing

• Nonoperative management between age 8-11 in early stage

  Patients who do not undergo some form of containment surgery because of medical, social, or other reasons will receive no surgical treatment.

  Treatment: Nonoperative Observation

• Operative containment with short-term non-weightbearing in early stage

  As per the current standard practice for patients between age 8-11 in developed countries, all patients will undergo some form of containment surgery (pelvic or femoral osteotomy) in order to better "contain" the femoral head underneath the acetabulum. Post-operative treatment will include 6 weeks of non-weight bearing on the operated leg.

  Treatment: Osteotomy + Short Term Non-Weight Bearing

• Operative containment with prolonged non-weightbearing in early stage

  As per the current standard practice for patients between age 8-11, all patients will undergo some form of containment surgery (pelvic or femoral osteotomy) in order to better "contain" the femoral head underneath the acetabulum. Post-operative treatment will include 6 months of non-weight bearing on the operated leg.

  Treatment: Osteotomy + Long Term Non-Weight Bearing

• Operative containment for over 11 age group

  Patients presenting over age 11 may receive multiple drilling and be non weight bearing for up to 6 months according to the treating physician's preference. Patients with application of fixator (arthrodiastasis) will be studied in this cohort arm as well, which typically involved 3-4 months followed by 8-12 weeks of non-weight bearing after fixator removal. Other surgical techniques may be included, however these are the most common for this age group.

  Treatment: Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, and Multiple Epiphyseal Drilling

• Nonoperative management in over 11 age group

  Patients will be non-weight bearing and receive physical therapy according to the physician preferences.

  Treatment: Nonoperative Observation

• Nonoperative management in 1-6 age group

  The choice of non-osteotomy management without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Nonoperative Observation

• Operative management in 1-6 age group

  The choice of osteotomy management with containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, and Multiple Epiphyseal Drilling

• Late Stage Bracing group

  Patients presenting with \<= 20 degrees of abduction on a maximum abduction x-ray treated with bracing who also present in the late stages of the disease (Waldenstrom Stage IIb or IIIa).The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Nonoperative Observation

• Late Stage Symptomatic treatment group

  Patients presenting in the late stages of the disease (defined as Waldenstrom stage IIb or IIIa) who are treated symptomatically. The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Nonoperative Observation

• Late Stage Surgical Containment group

  Patients presenting in the late stages of the disease (defined as Waldenstrom stage IIb or IIIa) who are treated with surgical containment. The choice of management with or without containment or surgical containment would be solely governed by the current practice of the participating surgeons (i.e. the current practice of the individual surgeon would be followed within the broad framework of the study).

  Treatment: Osteotomy + Long Term Non-Weight Bearing, Osteotomy + Short Term Non-Weight Bearing, and Multiple Epiphyseal Drilling