Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease

Conditions

• Legg Calve Perthes Disease

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Osteotomy + Long Term Non-Weight Bearing — PROCEDURE
  Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.
• Osteotomy + Short Term Non-Weight Bearing — PROCEDURE
  Surgical procedure that improves femoral head containment, plus a post-operative protocol that allows early return to function after 6 weeks of non-weight bearing.
• Nonoperative Observation — PROCEDURE
  Group will not undergo any surgical or invasive procedures during course of treatment.
• Multiple Epiphyseal Drilling — PROCEDURE
  Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.

Study Details

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. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, \>11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.

Key Dates

Start date

Aug 31, 2012

Status verified

May 2025

Primary completion

Sep 30, 2032

Completion

Sep 30, 2032

Study Design

Enrollment

1,500 participants (estimated)

Arms

• Arm: 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).
• Arm: 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
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: 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.
• Arm: Nonoperative management in over 11 age group
  Patients will be non-weight bearing and receive physical therapy according to the physician preferences.
• Arm: 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).
• Arm: 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).
• Arm: 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).
• Arm: 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).
• Arm: 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).

Primary Outcome Measure

Sphericity deviation score of the femoral head [ Time Frame: 5 years post intervention ]

Locations (28)

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