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NCT Number: NCT02121964

Capsulectomy vs Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

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.

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Key information

Conditions

Hip Arthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsulectomy in Direct Anterior Total Hip Arthroplasty

Procedure

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

Capsulotomy in Direct Anterior Total Hip Arthroplasty

Procedure

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

Primary outcomes

  1. Range of Motion- Resisted Hip Flexion Strength

    Time frame: Follow Up Visit (Up to six months)

    Measurement will be recorded taken with patient in the seated position with the hip flexed to 90 degrees. Strength will be measured when resistance is applied to the knee as the patient brings the leg up. The following scale will be used (each may be +/-, i.e. 5+):

    • 5 = NORMAL - the patient is able to actively move through the full available range of motion (ROM) against gravity and against maximal resistance
    • 4 = GOOD - the patient is able to actively move through the full available ROM against gravity and against moderate resistance
    • 3 = MODERATE - the patient is able to actively move through greater than one half the available ROM against gravity and against moderate resistance
    • 2 = POOR - the patient is unable to actively flex hip against gravity
    • 1 = BAD - the patient is unable to flex muscle properly

  2. Change in Range of Motion - Maximum Hip Flexion

    Time frame: Screening Visit, Follow-up visit (Up to six months)

    This angle will be measured with the patient in the supine position utilizing a goniometer (recorded in degrees). Patients will flex the hip by bringing their leg as close to their trunk as possible with their knee bent. The angle between the trunk and leg will be recorded

  3. Change in Range of Motion - Maximum Hip Extension

    Time frame: Screening Visit, Follow Up Visit (Up to six months)

    This angle will be measured with the patient in the prone position utilizing a goniometer. The patient will raise the lower leg to the limit of extension. The angle between the leg and table is recorded.

  4. Change in Range of Motion - Evidence of Flexion Contraction (Thomas Test)

    Time frame: Screening Visit, Follow Up Visit (Up to six months)

    This angle will be measured with the patient lying in the supine position. Patient will bring opposite knee to the chest, while the other leg remains extended. The angle between the extended leg and the table is recorded.

  5. Change in Pain Score with Resisted Hip Flexion

    Time frame: Screening Visit, Follow Up Visit (Up to six months)

    Measured using the Pain Assessment scale (PAS) of 0-10 (0 being no pain; 10 being worst imaginable pain).

Secondary outcomes

  1. Change in Hip Disability and Osteoarthritis Outcome Score

    Time frame: Screening Visit, Follow Up Visit (Up to six months)

    Hip disability and osteoarthritis outcome survey (HOOS) administered to patients.

  2. Surgical Time

    Time frame: Inpatient Surgery Visit (Day 0)

    This will be measured from the time of incision to the time the dressing is applied (per registered nurse (RN) operating room record).

  3. Transfusion Rate by Percent Hemoglobin Drop

    Time frame: Inpatient Surgery Visit (Day 0)

    This will be recorded by review of inpatient medical records. Percent hemoglobin drop will be measured by comparing the preoperative hemoglobin to the inpatient nadir hemoglobin.

  4. Number of Adverse Events

    Time frame: Duration of study (Up to six months)

    Patients will be assessed for complications that occur as a result of THA. These will be assessed at the standard of care intervals (6 week and 6 month follow-up visits). Any change in stem position including subsidence and radiolucencies will be reviewed.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Anterior Capsulectomy Versus Capsulotomy With Repair in Direct Anterior Total Hip Arthroplasty

Important dates

Study start
2013
Primary completion
2016
Study completion
2020
First posted
Apr 24, 2014
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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