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

NCT04638114 | Withdrawn DMC

• 1 other identifier: S53641
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoracetabular Impingement

Outcome Measures

Primary Outcomes (1)

• Validated outcome score

  Clinical outcome

  2 year

Secondary Outcomes (1)

• Radiographic measurement

  2 year

Study Arms (2)

CAM lesion

EXPERIMENTAL

Mini-Open DAA Hip Arthroscopy

Procedure: Mini-open DAA; Procedure: Hip arthroscopy

PINCER impingement

OTHER

Mini-Open DAA Hip Arthroscopy

Procedure: Mini-open DAA; Procedure: Hip arthroscopy

Interventions

Mini-open DAA PROCEDURE

Direct anterior approach hip

Also known as: DAA

CAM lesion; PINCER impingement

Hip arthroscopy PROCEDURE

arthroscopic treatment of hip pathology

CAM lesion; PINCER impingement

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 15-80 years
• Gender: 1:1 ratio of males and females / cohort
• BMI: \<30kg/m
• Symptomatic FAI proven by clinical examination, plain radiographs and positive arthro-CT examination.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Pellenberg

Pellenberg, 3212, Belgium

Location

Related Publications (1)

• Beck M, Leunig M, Parvizi J, Boutier V, Wyss D, Ganz R. Anterior femoroacetabular impingement: part II. Midterm results of surgical treatment. Clin Orthop Relat Res. 2004 Jan;(418):67-73.

  PMID: 15043095 RESULT

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigli Vanhooren

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

BE (1)