Late-presenting Hip Dislocation in Non-ambulatory Children With Cerebral Palsy: A Comparison of Three Procedures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMuhammad Ayoub

About this trial

Cerebral palsy (CP) is characterized by a fixed lesion that affects the neurological system during development. Pathologic hip conditions, such as subluxation or dislocation, are of great concern in non-ambulatory CP patients. Complete hip dislocations are commonly encountered in non-ambulatory CP patients and this can be quite problematic if pain is experienced or when sitting, balance, posture, or hygiene become affected.

The management of this patient population includes both reconstructive surgery, which aimed to center the dislocated femoral head into the acetabulum, and salvage surgeries, which are performed to reduce associated pain and/or functional deficits (e.g., sitting problems).

There are many options for salvage management of dislocated hips in CP patients, including proximal femoral resection (PFR) either with or without cartilage capping, proximal femoral valgus osteotomy, hip arthrodesis, and prosthetic hip arthroplasty.

To date, there is no conclusive evidence to determine which option is superior compared to the others in terms of efficacy and postoperative complications in CP patients due to the lack of a comparison group and the small number of included patients. Furthermore, the decision to take reconstructive vs. salvage procedures is still a matter of debate in the literature.

Therefore, this study is being conducted to compare outcomes between PFR, reconstructive hip surgery, and proximal femur valgus osteotomy in terms of clinical improvement (Including pain) and complications

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lesion: neglected deformed dislocated hip (Deformed head Group B, C, and D according to Rutz classification modified from MCPHCS )

Non-ambulatory: as defined by GMFCS level IV and V

Disqualifiers

Ambulatory patients

patients underwent any previous hip bony procedures.

Non-deformed Femoral head Group A according to Rutz classification

Neuromuscular hip dislocation other than cp.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hip reconstruction surgery.

    Procedure/Surgery

    This group will undergo Hip reconstruction surgery Anterior approach overlying the iliac crest: open reduction, pelvic osteotomy and pelvic osteotomy. Lateral approach: derotation-varization osteotomy and shortening of femur, internal fixation

  • Proximal femoral resection

    Procedure/Surgery

    Resection of the proximal part of the femur below the level of the lesser trochanter by 2 to 3 cm and constructed a capsular flap across the acetabulum. The quadriceps muscle will be sutured around the resected end of the femur

  • Proximal femoral valgus ostetomy

    Procedure/Surgery

    The patient is positioned in the lateral decubitus Position A straight incision is cantered over the greater trochanter and extends proximally. Head and neck are resected. A closing wedge, shortening, valgus-producing osteotomy of 40 to 50 degrees is marked just below the lesser trochanter and fixed by a plate

Treatment groups

51 Participants
are divided into 3 treatment groups
Group A: Hip Reconstruction surgery.Active comparator 1 intervention
Group B: Proximal femoral resectionActive comparator 1 intervention
Group C: Proximal femur valgus osteotomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Radiological changes

Plain radiograph x-ray is used to assess the Migration percentage

Time frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
2

Radiological changes

Plain radiograph x-ray is used to assess Pelvic obliquity

Time frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
3

Radiological changes

Plain radiograph x-ray is used to asses Acetabular index.

Time frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative
4

Radiological changes

Plain radiograph x-ray is used to assess Femoral head sphericity

Time frame
Immediately postoperative, 3 weeks postoperative, 3 months postoperative, and 6 months postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Ayoub

Lead sponsor

Ain Shams University

Sponsor institution