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Mini- Open Direct-anterior Approach vs Hip Arthroscopy for Treatment of Femoroacetabular Impingement.

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ClinicalTrials.gov Identifier: NCT04638114
Recruitment Status : Withdrawn (Investigator is no longer employed in study site)
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Femoroacetabular impingement (FAI) is increasingly recognized as a common hip condition affecting the adolescent and adult population with groin pain and disability 1-5. When nonsteroidal anti-inflammatory medications, activity modification and injections fail as conservative treatment option fails, surgery addressing the underlying osseous pathoanatomy and associated labral and chondral lesions may be necessary.

Several techniques have been described as treatment of this condition. The first technique termed surgical hip dislocation (SHD) allowed to describe the pathomechanism of FAI 1, 3, 5, 6 and to develop treatment strategies such as osteochondroplasty, acetabular rim resection and fixation of torn labrum. Other techniques also have been proposed and consist of less invasive techniques as the (mini-open) direct anterior approach 7-10 and ´the golden standard´; the hip arthroscopy 11-15.

Good results have been reported for all techniques but faster rehabilitation and less morbidity have been published for hip arthroscopy (HA). The direct anterior approach also shows good results but a good randomized controlled trial to compare both techniques has not yet been performed.

Outcome is meanly determined by adequate bony correction of cam and pincer deformities. Direct visualization during SHD offers the advantage that possibly a more appropriate correction of the underlying morphology can be done. This thereby decreases the likelihood of early hip osteoarthritis (OA).

The purpose of the present study was to test the hypothesis that 1) the postoperative recovery and short term outcome after HA is superior compared to mini-open direct anterior approach and 2) the morphological corrections achieved by HA are equally sufficient when compared to the corrections achieved by the mini-open direct anterior technique.


Condition or disease Intervention/treatment Phase
Femoracetabular Impingement Procedure: Mini-open DAA Procedure: Hip arthroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mini- Open Direct-anterior Approach vs Hip Arthroscopy for Treatment of Femoroacetabular Impingement. A Prospective Randomized Controlled Trial With 2 Years Follow up
Study Start Date : August 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Arm Intervention/treatment
Experimental: CAM lesion
Mini-Open DAA Hip Arthroscopy
Procedure: Mini-open DAA
Direct anterior approach hip
Other Name: DAA

Procedure: Hip arthroscopy
arthroscopic treatment of hip pathology

PINCER impingement
Mini-Open DAA Hip Arthroscopy
Procedure: Mini-open DAA
Direct anterior approach hip
Other Name: DAA

Procedure: Hip arthroscopy
arthroscopic treatment of hip pathology




Primary Outcome Measures :
  1. Validated outcome score [ Time Frame: 2 year ]
    Clinical outcome


Secondary Outcome Measures :
  1. Radiographic measurement [ Time Frame: 2 year ]
    Morphological Outcome parameter



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: 15-80 years
  2. Gender: 1:1 ratio of males and females / cohort
  3. BMI: <30kg/m
  4. Symptomatic FAI proven by clinical examination, plain radiographs and positive arthro-CT examination.
  5. Clinical inclusion criteria: A positive impingement sign together with hip internal rotation in the 90° flexed hip position of less than 10° are the main clinical criteria.
  6. Morphologic inclusion: a cam deformity (alpha angle higher 55°) 17 on radial arthro CT together with corresponding chondrolabral lesions

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638114


Locations
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Belgium
UZ Pellenberg
Pellenberg, Belgium, 3212
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Study Chair: Sigli Vanhooren
Publications of Results:
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04638114    
Other Study ID Numbers: S53641
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes