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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05310240
Other study ID # 1199/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date February 1, 2023

Study information

Verified date August 2023
Source Bezirkskrankenhaus St. Johann in Tirol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Joint-preserving surgery with arthroscopic techniques of the hip follows detailed radiological assessment including plain radiography of the hips and magnetic resonance arthrography (MRI). The purpose of this study was to compare features on radiography and MRI of the hip before surgery and assess their prognostic value on the outcome after surgery.


Description:

Hip arthroscopy is indicated for the treatment of a variety of pathologies of the hip, in patients without osteoarthritis. The diagnosis in patients with pain at the hip is made after history taking, clinical examination and radiological evaluation with plain radiography in a standardized technique and a magnetic resonance arthrography of the hip. The main indications for hip arthroscopy include CAM-type femoroacetabular impingement (FAI) necessitating bony decompression and chondro-labral tears necessitating arthroscopic repair or debridement. The purpose of this radiological non-interventional outcome study was to assess features on plain radiography and MRI in favor of good outcome after hip arthroscopy. This department performed 810 hip arthroscopies in the years of 2013 till 2021. All of those patients underwent standardized radiological evaluation with radiography and MRI. Radiographical parameters are assessed by a resident with experience in musculo-sceletal radiology, intra- and inter-observer reliability has been assessed for each parameter. All arthroscopies have been performed by two experience senior orthopedic surgeons. Ethical board approval has been obtained to follow-up on those patients. Follow-up includes the patient-reported outcome assessment using the iHOT12 score and the modified Harris hip score. The clinical end-point is the time till total hip arthroplasty (THA), a registry analysis of the Tyrolean Arthroplasty registry (TAR) has been performed. Statistical analysis is performed using ANOVA and Fishers T-Tests, the level of significance is .05.


Recruitment information / eligibility

Status Completed
Enrollment 810
Est. completion date February 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Hip arthroscopy from 2013-2021 at this department. Exclusion Criteria: - Age below 18 years.

Study Design


Intervention

Procedure:
Hip arthroscopy
Arthroscopic surgery of the hip

Locations

Country Name City State
Austria BKH St. Johann in Tirol Sankt Johann In Tirol Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Bezirkskrankenhaus St. Johann in Tirol

Country where clinical trial is conducted

Austria, 

References & Publications (2)

McCarthy JC, Glassner PJ. Correlation of magnetic resonance arthrography with revision hip arthroscopy. Clin Orthop Relat Res. 2013 Dec;471(12):4006-11. doi: 10.1007/s11999-013-3202-5. Epub 2013 Aug 1. — View Citation

Ross JR, Larson CM, Bedi A. Indications for Hip Arthroscopy. Sports Health. 2017 Sep/Oct;9(5):402-413. doi: 10.1177/1941738117712675. Epub 2017 Jul 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary prosthetic-free survival The number of days between hip arthroscopy and total hip arthroplasty. This parameter is assessed with the help of a joint-replacement registry for all subjects. Through study completion, an average of 1 year
Secondary iHOT12 Score Patient reported outcome measurement with validation for patients after hip arthroscopy Through study completion, an average of 1 year
Secondary modified Harris-Hip score Patient reported outcome measurement with validation for failure of joint-preserving procedures Through study completion, an average of 1 year
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