Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

NCT ID: NCT02121964

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2020-05-31

Brief Summary

In this prospective, randomized study, investigators will look at the outcome of total hip arthroplasty through the anterior approach in regard to the surgical treatment of the anterior hip capsule. At this time, there are 2 different techniques: one is excising this capsule and the second one is cutting the capsule and repairing it at the end of the procedure. The investigators set out to determine whether incising or repairing the capsule will benefit the patients in terms of postoperative pain level, range of motion of the hip joint, joint stability, surgical time and blood loss. Both preserving and excising the joint capsule are accepted techniques in performing total hip arthroplasty. The Investigators hypothesize that capsulectomy may allow for reduction in operative time, provide superior surgical exposure, and increased range of motion after surgery. The influence on post operative pain and dislocation rate is unknown.

Detailed Description

Utilization of the direct anterior approach for total hip arthroplasty (THA) has increased over the last ten years. The approach, as described by Keggi et al, superficially utilizes the internervous muscle plane between the tensor fascia lata and the sartorius and deeply between the rectus and gluteus medius (1). Performing this muscle sparing rather than muscle splitting approach has several purported benefits. The clinical reports of this surgical approach have documented low dislocation rates (2, 3), excellent cup position (4) improved outcome scores (5), less muscle damage (6, 7) and improved gait mechanics (8). The preservation and repair of the anterior hip capsule (iliofemoral and pubofemoral ligaments) has been recommended by some authors, while anterior capsulectomy has been described by other authors without a reported increase in dislocation rate. In contrast, the higher risk of posterior dislocation using the posterior approach improved significantly after repair of the capsule (9, 10). There are no studies to date that have investigated outcome scores based on capsular repair versus capsulectomy for the THA direct anterior approach. The effects of anterior capsular repair versus capsulectomy are unknown with regards to anterior hip pain, range of motion, and surgical recovery. We hypothesize that capsulectomy may allow for reduction in operative time, provide superior surgical exposure, and increased range of motion after surgery. The influence on post operative pain and dislocation rate is unknown.

In this prospective, randomized clinical study investigators will compare operative time, blood loss, postoperative pain, range of motion, strength, and adverse events using two different surgical techniques (anterior capsular repair versus anterior capsulectomy) during direct anterior total hip arthroplasty. Patients will be randomized at their screening visit to one of two groups (anterior capsule repair or anterior capsulectomy), and they will be blinded for the group assignment. The surgical procedures will be performed according to the surgeon's routine standard of care.

Conditions

Hip Arthrosis; Osteoarthritis; Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Capsulectomy

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Group Type: OTHER

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Intervention Type: PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.

Capsulotomy

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Group Type: OTHER

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Intervention Type: PROCEDURE

Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Interventions

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.

Intervention Type: PROCEDURE

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Elective unilateral or bilateral primary total hip arthroplasty
• Direct anterior surgical approach
• Osteoarthritis diagnosis
• 18 years of age or older

Exclusion Criteria

• Revision hip arthroplasty
• Avascular necrosis of the hip
• Rheumatoid arthritis of the hip
• Younger than 18 years of age

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Thomas L Bradbury, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas L Bradbury, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

Countries

United States

References

Keggi KJ, Huo MH, Zatorski LE. Anterior approach to total hip replacement: surgical technique and clinical results of our first one thousand cases using non-cemented prostheses. Yale J Biol Med. 1993 May-Jun;66(3):243-56.

Reference Type: BACKGROUND

PMID: 8209560 (View on PubMed)

Matta JM, Shahrdar C, Ferguson T. Single-incision anterior approach for total hip arthroplasty on an orthopaedic table. Clin Orthop Relat Res. 2005 Dec;441:115-24. doi: 10.1097/01.blo.0000194309.70518.cb.

Reference Type: BACKGROUND

PMID: 16330993 (View on PubMed)

Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.

Reference Type: BACKGROUND

PMID: 21076896 (View on PubMed)

Masonis J, Thompson C, Odum S. Safe and accurate: learning the direct anterior total hip arthroplasty. Orthopedics. 2008 Dec;31(12 Suppl 2):orthosupersite.com/view.asp?rID=37187.

Reference Type: BACKGROUND

PMID: 19298019 (View on PubMed)

Restrepo C, Parvizi J, Pour AE, Hozack WJ. Prospective randomized study of two surgical approaches for total hip arthroplasty. J Arthroplasty. 2010 Aug;25(5):671-9.e1. doi: 10.1016/j.arth.2010.02.002. Epub 2010 Apr 8.

Reference Type: BACKGROUND

PMID: 20378307 (View on PubMed)

Bremer AK, Kalberer F, Pfirrmann CW, Dora C. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg Br. 2011 Jul;93(7):886-9. doi: 10.1302/0301-620X.93B7.25058.

Reference Type: BACKGROUND

PMID: 21705558 (View on PubMed)

Meneghini RM, Pagnano MW, Trousdale RT, Hozack WJ. Muscle damage during MIS total hip arthroplasty: Smith-Petersen versus posterior approach. Clin Orthop Relat Res. 2006 Dec;453:293-8. doi: 10.1097/01.blo.0000238859.46615.34.

Reference Type: BACKGROUND

PMID: 17006366 (View on PubMed)

Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.

Reference Type: BACKGROUND

PMID: 19699566 (View on PubMed)

Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.

Reference Type: BACKGROUND

PMID: 9917607 (View on PubMed)

Weeden SH, Paprosky WG, Bowling JW. The early dislocation rate in primary total hip arthroplasty following the posterior approach with posterior soft-tissue repair. J Arthroplasty. 2003 Sep;18(6):709-13. doi: 10.1016/s0883-5403(03)00254-7.

Reference Type: BACKGROUND

PMID: 14513442 (View on PubMed)

Schwartz AM, Goel RK, Sweeney AP, Bradbury TL Jr. Capsular Management in Direct Anterior Total Hip Arthroplasty: A Randomized, Single-Blind, Controlled Trial. J Arthroplasty. 2021 Aug;36(8):2836-2842. doi: 10.1016/j.arth.2021.03.048. Epub 2021 Mar 26.

Reference Type: DERIVED

PMID: 33865648 (View on PubMed)

Other Identifiers

IRB00054340

Identifier Type: -

Identifier Source: org_study_id