Modified Arthroscopy Tools for Hip Surgery

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Age <18, Prisoners, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

111 Participants Needed

Trial Summary

What is the purpose of this trial?

This is protocol is intended to demonstrate the principal investigator's improvements and modifications of a hip capsule side fixed slotted cannula for continued access to the hip joint and a bone graft delivery tool set for grafting subchrondral cysts during hip arthroscopy procedure.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Modified bone graft delivery tool set, Modified hip capsule side fixed slotted cannula for hip surgery?

The use of slotted cannulas in hip arthroscopy allows for safer introduction of curved instruments into the hip joint, reducing the risk of damage to the joint. Additionally, modified portals for hip arthroscopy can minimize damage to surrounding tissues and improve access to the hip joint, which may enhance the effectiveness of surgical procedures. ^{1 2 3 4 5}

How is the treatment 'Modified Arthroscopy Tools for Hip Surgery' different from other treatments?

This treatment is unique because it uses a modified bone graft delivery tool set and a slotted cannula, which allows for the introduction of curved instruments into the hip joint with less risk of damage to the cartilage. The slotted cannula can be removed for better instrument mobility, making the procedure more efficient and potentially safer compared to traditional methods that use larger or flexible cannulas. ^{1 2 4 6 7}

Research Team

Omer Mei-Dan, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults aged 18-60 with persistent hip pain and mechanical symptoms that haven't improved with non-surgical treatments. They should have specific signs of impingement or limited motion, confirmed by imaging tests, and sufficient joint space. It's not open to minors, prisoners, pregnant women, those who are decisionally challenged or don't understand English.

Inclusion Criteria

I have had hip pain for over 3 months that hasn't improved with non-surgical treatments.

My joint space is wider than 3 mm on all X-ray and CT scan images.

I have joint pain, limited movement, and my scans show joint issues.

Exclusion Criteria

Prisoners

I have difficulty making decisions due to my health condition.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hip arthroscopy using modified devices for improved surgical flow and technique

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits at Week 6, Month 3, Month 6, Month 12, Month 24

Treatment Details

Interventions

• Modified bone graft delivery tool set
• Modified hip capsule side fixed slotted cannula

Trial Overview The study is testing modified surgical tools in hip arthroscopy: a slotted cannula designed for better access to the hip joint and a tool set for delivering bone grafts to treat cysts. The goal is to see if these new tools improve the procedure.

Participant Groups

Group I: Arthroscopic bone grafting Active Control 2 Interventions

Patients undergoing arthroscopic bone grafting of subchrondral cyst with the use of the modified bone graft delivery tool set and modified hip capsule slotted cannula.

Group II: Arthrosocpic labral repair Active Control 1 Intervention

Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A minimalist approach to hip arthroscopy: the slotted cannula. [2014]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The modified mid-anterior portal for hip arthroscopy. [2021]

3. China pubmed.ncbi.nlm.nih.gov

[Arthroscopy-guided core decompression and bone grafting combined with selective arterial infusion for treatment of early stage avascular necrosis of femoral head]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Basic Hip Arthroscopy: Anatomic Establishment of Arthroscopic Portals Without Fluoroscopic Guidance. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Hip arthroscopy using a limited anterior exposure: an alternative approach for arthroscopic access. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Hip arthroscopy for the management of trauma: a literature review. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

'Single-side' graft hip reconstruction in the deficient acetabulum: a case report demonstrating a surgical technique. [2014]