Total Hip ArthroplastyNCT06176612
In Patients With Hip Dysplasia, Mid-Term Lower Extremities and Spine After Hip Arthroplasty Natural Course
A study testing total hip arthroplasty in people with Total Hip Arthroplasty, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with unilateral Crowe type 3 hip dysplasia
- Patients with unilateral Crowe type 4 hip dysplasia
Who cannot join
- Patients with unilateral Crowe type 1 hip dysplasia
- Patients with unilateral Crowe type 2 hip dysplasia
- History of previous surgery on the hip for which surgery is planned
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Fatih, 34093
About this study
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
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.
Read the detailed 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).
- Conditions
- Total Hip Arthroplasty
- Being tested
- total hip arthroplasty
- Keywords
- hip, Total hip arthroplasty, developmental hip dysplasia
- Medical subject headings
- Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplastyProcedure or surgery
Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent hip replacement
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement | Experimental | Not described Receives: Procedure: total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (5)
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.
Measured: From enrollment to the end of treatment at 2 years
The femoral offset (FO)
the vertical distances from the center of the femoral head to the center of the femoral canal
Measured: From enrollment to the end of treatment at 2 years
The hip-knee-ankle angle (HKA)
the angle formed by the mechanical axis of the femur and the mechanical axis of the tibia
Measured: From enrollment to the end of treatment at 2 years
The lateral distal femoral angle (LDFA)
the angle formed by the anatomic axis of the femur and the distal femoral joint orientation line
Measured: From enrollment to the end of treatment at 2 years
The medial proximal tibial angle (MPTA)
the angle formed by the anatomic axis of the tibia and the proximal tibial joint orientation line
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Apr 2021
- Primary completion15 Nov 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176612
- Sponsor's protocol ID
- A10207
- Status last verified
- Mar 2025
- First submitted
- 10 Dec 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not think it is right that the data of the patients in the study can be seen by everyone.
Publications
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 Nov;54(6):583-586. doi: 10.5152/j.aott.2020.19043.
PubMed 33423988Zhao 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: 10.1016/j.arth.2019.04.028. Epub 2019 Apr 20.
PubMed 31103361Kocabiyik 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 of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1.
PubMed 28641973
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06176612
- Acronym / sponsor ID
- A10207
- Conditions
- Total Hip Arthroplasty
- Keywords
- hip, Total hip arthroplasty, developmental hip dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement | Experimental | Procedure: total hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unilateral Crowe type 3 hip dysplasia
- Patients with unilateral Crowe type 4 hip dysplasia
Key exclusion criteria (3 listed)
- Patients with unilateral Crowe type 1 hip dysplasia
- Patients with unilateral Crowe type 2 hip dysplasia
- History of previous surgery on the hip for which surgery is planned
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip arthroplastyPatients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent hip replacement | Procedure or surgery | Patients with Crowe type 3 or Crowe type 4 hip dysplasia who underwent total hip replacement |
Primary outcome
Mechanical axis deviation (MAD)
Time frame: From enrollment to the end of treatment at 2 years
the lower limb was defined as the distance from the center of the knee to the mechanical axis of the lower limb
5 secondary outcomes
tibiofemoral angle (TFA)
Time frame: From enrollment to the end of treatment at 2 years
The femoral offset (FO)
Time frame: From enrollment to the end of treatment at 2 years
The hip-knee-ankle angle (HKA)
Time frame: From enrollment to the end of treatment at 2 years
The lateral distal femoral angle (LDFA)
Time frame: From enrollment to the end of treatment at 2 years
The medial proximal tibial angle (MPTA)
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Results publication: PubMed 33423988Can 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 Nov;54(6):583-586. doi: 10.5152/j.aott.2020.19043.
- Results publication: PubMed 31103361Zhao 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: 10.1016/j.arth.2019.04.028. Epub 2019 Apr 20.
- Results publication: PubMed 28641973Kocabiyik 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 of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1.
- Individual participant dataSharing planned: No. I do not think it is right that the data of the patients in the study can be seen by everyone.
Related trials for Total Hip Arthroplasty
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip arthroplasty in people with Total Hip Arthroplasty, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical axis deviation (MAD) (time frame: From enrollment to the end of treatment at 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06176612, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.