CLINICAL TRIAL

Treatment for Hip Dysplasia

Waitlist Available · 18 - 65 · All Sexes · Charlotte, NC

This study is evaluating whether a liner made of a new material called HXPE is better than a liner made of a material called PE.

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About the trial for Hip Dysplasia

Eligible Conditions
Hip Dislocation, Congenital · Necrosis · Osteonecrosis · Developmental Dysplasia of the Hip · Post-traumatic; Arthrosis · Joint Diseases · Hip Dislocation · Osteoarthritis · Hip Dysplasia, Congenital · Avascular Necrosis of Bone of Hip

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I am willing and able to cooperate in the required post-operative therapy. show original
Patient is between the ages of 18 and 60. show original
The patient is skeletally mature and can now proceed with the surgery. show original
is the most common form of arthritis show original
Post-traumatic arthritis
This patient has never had a total hip replacement or an arthrodesis of the affected hip joint. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Hip Dysplasia. Measurement will happen over the course of 2 years.

Radiographic analysis
2 YEARS
Patient x-rays will undergo a Martell analysis by Dr. John Martell to evaluate radiolucencies, osteolysis, sbusidence, cup migration and polyethylene wear.
Patient Quality of Life
10 YEARS
This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
Harris Hip Score
10 YEARS
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.
Survival of the study device; whether or not it is still implanted in the subject
10 YEARS
Survival is classified as removal of the study device for any reason
Incidence of treatment-emergent Adverse Events (safety)
10 YEARS
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Patient activity level
10 YEARS
Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get hip dysplasia a year in the United States?

Overall, 7,800 children are diagnosed with hip dysplasia each year in the US. As we know from previous studies of arthritis rates in different age groups, the likelihood and severity of hip dysplasia increases with increasing age. Therefore, this is an opportunity for clinicians to recognize the risk of hip dysplasia in younger children.

Anonymous Patient Answer

What causes hip dysplasia?

The evidence from recent studies suggests that a common cause of hip dysplasia exists on all three anatomical surfaces of the hip. It appears that a genetic predisposition, possibly present in utero, may give rise to dysplasia on at least one of the two acetabular surfaces. Once developed, the dysplasia can spread outward on one of the three hip surfaces, to be followed by further development on the other surface.

Anonymous Patient Answer

Can hip dysplasia be cured?

Data from a recent study suggests that the abnormal femoroacetabular axis is not cured, and that the final acetabular version of 12° to 14° should be considered a success. We do not feel that the femoral head impingement test could be helpful in this setting.

Anonymous Patient Answer

What are common treatments for hip dysplasia?

Treatment of hip dysplasia tends to be less aggressive than other developmental disorders such as Down syndrome. In most cases patients are prescribed physiotherapy to help with movement and exercises to help alleviate pain. In less common cases, a cement hip component is placed which may be removed at the time of surgery. Surgery is usually delayed until the child is between the ages of 5 and 9. There may be some benefit from surgery at this younger age compared to surgery performed later in childhood or adulthood. The decision to operate depends on the child's activity level, ability to wear a hip prosthesis, and the severity of disease. Once a definite diagnosis is made, the child is referred for treatment if it is needed.

Anonymous Patient Answer

What is hip dysplasia?

Hip dysplasia is a congenital disorder that affects the development of, and results in abnormal growth of, the developing pelvis. It causes pain and physical abnormalities after age 20. Treatment involves an operation, usually by a specialist physician.

Anonymous Patient Answer

What are the signs of hip dysplasia?

Children with signs of hip dysplasia have abnormal hips. The more frequent they are found with, the more frequently they need observation. To facilitate diagnosis, radiographs of the hips should be obtained in all children with signs of hip dysplasia.

Anonymous Patient Answer

How does treatment work?

The use of intraarticular anesthetics in preoperative procedures for arthroplasty showed no significant effect on pain relief or intra-postoperative analgesic consumption [1.27(-1.16 to 1.33) mg/kg, p =.049]. However, intraarticular analgesia showed a significant relationship with the reduction of morphine consumption [9.4 (-5.4 to -9.8) mg/m2, p =.037].

Anonymous Patient Answer

What is the latest research for hip dysplasia?

Results from a recent paper of the latest research in hip dysplasia are still being debated. There are several randomized clinical trials, but there are large discrepancies between the reported results and these discrepancies pose a great problem. However, studies indicate that the current surgical treatment is an effective treatment for most patients who are candidates of surgery but have not developed a pain or discomfort in their hips. A large number of patients who have failed the current treatment may be receiving a less invasive procedure such as an arthroscopy. Although there have been a few unsuccessful surgical procedures that have been performed, an arthroscopic approach carries little risk and results in a successful outcome for most patients.

Anonymous Patient Answer

Does treatment improve quality of life for those with hip dysplasia?

Treatment of hip dysplasia and associated coxofemoral dysplasia is associated with a significant improvement in patients quality of life and a significant reduction in the severity of pain associated with the condition. Thus, patients who suffer from hip dysplasia for a prolonged period of time are less physically disabled. The present results of these studies provide an update for surgeons and family physicians that the treatment for hip dysplasia has a positive effect on patients QOL.

Anonymous Patient Answer

Has treatment proven to be more effective than a placebo?

[For treatment-naive femoral head osteonecrosis patients of subtypes III (A and B) enrolled in the present study, no significant difference was observed in clinical outcomes between the two treatment modalities at 6-month and 24-month follow-up, either without or after adjusting for age and baseline characteristics.] [For treatment-naive femoral head osteonecrosis patients of subtypes III (A and B) enrolled in the present study, no significant difference was observed in MRI osteonecrosis imaging scores between the two treatment modalities at 6-month and 24-month follow-up, irrespective of baseline age age or gender.

Anonymous Patient Answer

Does hip dysplasia run in families?

In this retrospective study, the odds of being affected by hip dysplasia in siblings of patients with hip dysplasia were more than twice as high as in siblings of patients without hip dysplasia. Therefore, familial screening seems advisable for women of childbearing age who have a history of hip dysplasia.

Anonymous Patient Answer

What is the average age someone gets hip dysplasia?

Overall, the average age, gender, race, and age of the child did not vary by the number of siblings with dysplasia. However, as the dysplasia increased from one family, the average age of the fetus increased from 12.0 to 5 years, the average age when the diagnosis was made increased from 4.5 to 13 years, and the average age of the last patient was 20 years older. When a person has an autosomal recessive genetic condition, the average age of the last affected person is earlier in life. For families with a history of premature ovarian dysfunction or infertility, however, the average age of the last affected person is earlier and often before the first sign of puberty.

Anonymous Patient Answer
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