Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.

• ClinicalTrials.gov Identifier: NCT02032017
• Recruitment Status: Unknown
• First Posted: January 9, 2014
• Last Update Posted: January 9, 2014
• Sponsor: Universiteit Antwerpen
• Collaborator: Stöpler Belgium nv
• Information provided by (Responsible Party): Claudia Hendrickx, Universiteit Antwerpen

Tracking Information

• First Submitted Date: January 7, 2014
• First Posted Date: January 9, 2014
• Last Update Posted Date: January 9, 2014
• Study Start Date: October 2013
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2014)

change in time needed for the timed get up and go test [ Time Frame: baseline, 4 weeks, 12 weeks ]

The subject is asked to stand up from a chair, walk 3m to a cone, return to the chair and sit down again. The time needed to perform this test is recorded in seconds.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: January 8, 2014)

• surface electromyography (sEMG) of gluteus medius [ Time Frame: baseline ]
  sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
• Change in hip abductor muscle strength measured by MicroFET 2 [ Time Frame: baseline, 4 weeks, 12 weeks ]
  The patient lies supine. Resistance is administered on the lateral side of the leg, just proximal of the knee joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded.
• Change in knee extensor muscle strength measured by MicroFET 2 [ Time Frame: baseline, 4 weeks, 12 weeks ]
  The patient is seated with the hips and knees bent 90°. Resistance is administered on the ventral side of the leg, just proximal of the ankle joint. Patients will be asked for a maximally voluntary isometric contraction. The test will be repeated 3 times. The mean value will be recorded.
• Score on the Trendelenburg test [ Time Frame: baseline ]
  The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed:

  1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds
  2. The pelvis on the non-stance side can be lifted, but not maximally
  3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.
  4. No elevating of the pelvis on the non-stance side
  5. Drooping of the pelvis
  6. Non-valid response: due to hip pain or uncooperative patient
• Change in score on the Oxford Hip Score [ Time Frame: baseline, 4 weeks, 12 weeks ]
  The Oxford Hip Score (OHS) is a disease-specific questionnaire that consists of 12 questions for the evaluation of pain and hip function in relation to various activities. Each question contains 5 quantifiable answers, leading to a total score that can range from 12 (least problems) to 60 (most problems).
• Change in score on the SF-36 and it's subscales [ Time Frame: baseline, 4 weeks, 6 weeks ]
  The SF-36 is a generic questionnaire that contains 36 items measuring health on 8 different dimensions. These dimensions cover functional status, wellbeing and overall evaluation of health.
• Change in time needed to complete the 5 times sit-to-stand test [ Time Frame: baseline, 4 weeks, 12 weeks ]
  This easily feasible test where the patient has to stand up and sit back down 5 times as fast as possible is a good predictor of falling. A worse score (i.e. a longer time needed to complete the test) on the 5 times sit to stand (5tSTS) implies a greater chance of falling.
• Change in distance walked during the 6 minute walking test [ Time Frame: baseline, 4 weeks, 12 weeks ]
  The test measures the distance a patient can quickly walk on a flat, hard surface in a time-period of 6 minutes.
• surface electromyography (sEMG) of gluteus medius [ Time Frame: 4 weeks ]
  sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
• surface electromyography (sEMG) of gluteus medius [ Time Frame: 12 weeks ]
  sEMG of the gluteus medius is recorded during maximally voluntary isometric contraction and during single leg stance.
• Score on the trendelenburg test [ Time Frame: 4 weeks ]
  The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed:

  1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds
  2. The pelvis on the non-stance side can be lifted, but not maximally
  3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.
  4. No elevating of the pelvis on the non-stance side
  5. Drooping of the pelvis
  6. Non-valid response: due to hip pain or uncooperative patient
• Score on the Trendelenburg test [ Time Frame: 12 weeks ]
  The patient is asked to raise one leg (sound side) and lift the non-stance side of the pelvis as high as possible for 30 seconds. The response is classified as followed:

  1. Normal: the pelvis on the non-stance side can be lifted maximally during 30 seconds
  2. The pelvis on the non-stance side can be lifted, but not maximally
  3. The pelvis on the non-stance side is elevated, but not maintained for 30 seconds.
  4. No elevating of the pelvis on the non-stance side
  5. Drooping of the pelvis
  6. Non-valid response: due to hip pain or uncooperative patient

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.
• Official Title: Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation Compared to the Anterolateral Approach.
• Brief Summary: The purpose of this study is to investigate whether revalidation following total hip replacement through the percutaneous approach is faster or better than following the anterolateral approach. We assume this would be the case since it is possible to spare a large part of the gluteus medius muscle with the percutaneous approach.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Total Hip Arthroplasty

Intervention

• Procedure: Ceramic on ceramic couple
  All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.
• Procedure: Percutaneous assisted approach
• Procedure: Anterolateral approach
• Other: Usual care
  Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.

Study Arms

• Experimental: Percutaneous assisted approach
  In this technique, a second small incision (1 cm) at the anterior border of the femur is made. A canulla is placed underneath the muscle and used to pass the reamers in the direction of the acetabulum. There's no need to enlarge the skin incision or to release more muscle insertion to achieve good working access to the acetabulum. Two advantages can be defined: sparing of the gluteus medius muscle and safe access to the acetabulum to obtain perfect positioning of the implants.
  Interventions:

  • Procedure: Ceramic on ceramic couple
  • Procedure: Percutaneous assisted approach
  • Other: Usual care
• Active Comparator: Anterolateral approach
  A standard transgluteal approach is used. This means a large part of the gluteus medius muscle is released to obtain good access to the acetabulum.
  Interventions:

  • Procedure: Ceramic on ceramic couple
  • Procedure: Anterolateral approach
  • Other: Usual care

• Publications *: Hendrickx C, De Hertogh W, Van Daele U, Mertens P, Stassijns G. Effect of percutaneous assisted approach on functional rehabilitation for total hip replacement compared to anterolateral approach: study protocol for a randomized controlled trial. Trials. 2014 Oct 8;15:392. doi: 10.1186/1745-6215-15-392.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 8, 2014): 30
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• unilateral hip arthritis or avascular necrosis (AVN) in need for total hip replacement

Exclusion Criteria:

• Comorbidities affecting functional outcome
• Symptomatic lumbar pathology
• Need of surgery or intervention on the ipsilateral knee and/or ankle/foot
• Neurological disorders such as Parkinsonism and previous cardiovascular accidents (CVA)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT02032017
• Other Study ID Numbers: B300201318915
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Claudia Hendrickx, Universiteit Antwerpen
• Study Sponsor: Universiteit Antwerpen
• Collaborators: Stöpler Belgium nv

Investigators

• Principal Investigator: Claudia Hendrickx, PhD student; Universiteit Antwerpen

• PRS Account: Universiteit Antwerpen
• Verification Date: January 2014