In Patients With Hip Dysplasia, Mid-Term Lower Extremities and Spine After Hip Arthroplasty Natural Course

Total Hip Arthroplasty Clinical Trial

Official title:

In Patients With Crowe Type III and Crowe Type IV Hip Dysplasia, Mid-Term Lower Extremities and Spine After Total Hip Arthroplasty Natural Course

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06176612
• Other study ID #: A10207
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: December 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with developmental hip dysplasia often present to the outpatient clinic in adulthood with hip pain due to progressive hip osteoarthritis. However, they may have complaints such as limping, lumbar lordosis, lower back pain, and leg length difference. Today, the best treatment option for these patients is hip arthroplasty. Hip arthroplasty causes a high rate of functional improvement and pain relief. According to the hip arthroplasty technique applied, improvement in lameness, leg length difference and spinal curvatures is expected. The aim of our study is to show the change in postoperative spine and lower extremity curvatures after hip arthroplasty in patients with advanced developmental hip dislocation.

Description:

Developmental hip dysplasia (DDH) describes the spectrum of anatomical changes in the acetabulum and proximal femur; these can cause limping, lower back pain, lumbar lordosis, and leg length variation. DDH is the main cause of degenerative arthritis of the hip and valgus deformity of the knee. The best treatment option for DDH is total hip arthroplasty (THA). During THA, the distorted anatomy of the acetabulum and proximal femur poses great difficulties. Additionally, the soft tissue can be released and the femur can be shortened while correcting the placement of the acetabulum to prevent neurological damage (sciatic nerve paralysis). Postoperative evaluations focused on assessing joint function and alleviating preoperative clinical symptoms. Some studies have examined changes in lower extremity and knee alignment after THA in patients with DDH. In patients with DDH, THA may cause genu valgus deformity due to increased lower extremity length and Q angle immediately after the operation. THA extends the lower extremity, affecting the patellofemoral joint and anterior knee pain. However, the long-term effects of THA on the alignment of the lower extremity are unclear, especially in patients with Crowe type III and IV DDH, which involves femoral shortening osteotomy. There are few studies examining changes in the knee and lower extremities as a result of THA in patients with DDH. The aim of this study is to evaluate the mid- and long-term alignment of the spine and lower extremity after THA with or without femoral shortening osteotomy in patients with unilateral DDH (Crowe type III-IV).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: January 1, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients with unilateral Crowe type 3 hip dysplasia

2. Patients with unilateral Crowe type 4 hip dysplasia

Exclusion Criteria:

1. Patients with unilateral Crowe type 1 hip dysplasia

2. Patients with unilateral Crowe type 2 hip dysplasia

3. History of previous surgery on the hip for which surgery is planned

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Total Hip Arthroplasty

Intervention

Procedure:
• total hip arthroplasty
Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent hip replacement

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Can A, Erdogan F, Yontar NS, Ovul Erdogan A, Erdem MN, Sarikaya IA. Spinopelvic alignment does not change after bilateral total hip arthroplasty in patients with bilateral Crowe type-IV developmental dysplasia of the hip. Acta Orthop Traumatol Turc. 2020 — View Citation

Kocabiyik A, Misir A, Kizkapan TB, Yildiz KI, Kaygusuz MA, Alpay Y, Ezici A. Changes in Hip, Knee, and Ankle Coronal Alignments After Total Hip Arthroplasty With Transverse Femoral Shortening Osteotomy for Unilateral Crowe Type IV Developmental Dysplasia — View Citation

Zhao HY, Kang PD, Shi XJ, Zhou ZK, Yang J, Shen B, Pei FX. Effects of Total Hip Arthroplasty on Axial Alignment of the Lower Limb in Patients with Unilateral Developmental Hip Dysplasia (Crowe type IV). J Arthroplasty. 2019 Oct;34(10):2406-2414. doi: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical axis deviation (MAD)	the lower limb was defined as the distance from the center of the knee to the mechanical axis of the lower limb	From enrollment to the end of treatment at 2 years
Secondary	tibiofemoral angle (TFA)	the angle formed by the line from the center of the femoral canal to the center of the knee joint and the line from the center of the knee joint to the center of the ankle joint.	From enrollment to the end of treatment at 2 years
Secondary	The femoral offset (FO)	the vertical distances from the center of the femoral head to the center of the femoral canal	From enrollment to the end of treatment at 2 years
Secondary	The hip-knee-ankle angle (HKA)	the angle formed by the mechanical axis of the femur and the mechanical axis of the tibia	From enrollment to the end of treatment at 2 years
Secondary	The lateral distal femoral angle (LDFA)	the angle formed by the anatomic axis of the femur and the distal femoral joint orientation line	From enrollment to the end of treatment at 2 years
Secondary	The medial proximal tibial angle (MPTA)	the angle formed by the anatomic axis of the tibia and the proximal tibial joint orientation line	From enrollment to the end of treatment at 2 years