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A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Primary Purpose

Arthritis, Avascular Necrosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Anterolateral approach
Posterior approach
ReCap Total Hip Resurfacing
ReCap Total Hip Resurfacing
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

29 Years - 61 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary hip OA
  • Secondary hip OA due to mild and moderate acetabular dysplasia
  • Sufficient bone quality for cementless acetabular component
  • Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
  • >29 years
  • <61 years

Exclusion Criteria:

  • Neuromuscular or vascular diseases in affected leg
  • Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
  • Need of NSAID post-operatively
  • Fracture sequelae
  • Females at risk of pregnancy (no safe contraceptives)
  • Severe hip dysplasia
  • Sequelae from hip disease in childhood
  • Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
  • Alcoholism (females > 14 units per week, males > 21 units per week) AVN
  • Osteoporosis

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.

This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.

Outcomes

Primary Outcome Measures

RSA

Secondary Outcome Measures

Harris Hip Score
Microdialysis
Conventional X-ray
Gait Analysis
DEXA scan

Full Information

First Posted
September 10, 2008
Last Updated
January 9, 2018
Sponsor
Zimmer Biomet
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00750984
Brief Title
A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Official Title
A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Detailed Description
Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy: Less bone resection, less complicated revision surgery. Reduced stress shielding of the femur. Lower incidence of hip dislocations. Walking function improved by change in mobilisation regime and operative technique. Risk of femoral neck fracture is reduced by preoperative measurement of bone density. Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Avascular Necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Arm Title
2
Arm Type
Active Comparator
Arm Description
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Intervention Type
Procedure
Intervention Name(s)
Anterolateral approach
Intervention Description
The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.
Intervention Type
Procedure
Intervention Name(s)
Posterior approach
Intervention Description
The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.
Intervention Type
Device
Intervention Name(s)
ReCap Total Hip Resurfacing
Intervention Description
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Intervention Type
Device
Intervention Name(s)
ReCap Total Hip Resurfacing
Intervention Description
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
Primary Outcome Measure Information:
Title
RSA
Time Frame
1 week, 3 months, 1 year, 2 years, 5 years
Secondary Outcome Measure Information:
Title
Harris Hip Score
Time Frame
Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
Title
Microdialysis
Time Frame
1 week
Title
Conventional X-ray
Time Frame
1 week
Title
Gait Analysis
Time Frame
1 week, 3 months, 1 year
Title
DEXA scan
Time Frame
Pre-operatively, 1 week, 1 year, 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary hip OA Secondary hip OA due to mild and moderate acetabular dysplasia Sufficient bone quality for cementless acetabular component Suited for resurfacing of the femoral head (pre- and intraoperatively assessed) >29 years <61 years Exclusion Criteria: Neuromuscular or vascular diseases in affected leg Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component Need of NSAID post-operatively Fracture sequelae Females at risk of pregnancy (no safe contraceptives) Severe hip dysplasia Sequelae from hip disease in childhood Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic) Alcoholism (females > 14 units per week, males > 21 units per week) AVN Osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pryno, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kjeld Soeballe, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Arhus
Country
Denmark

12. IPD Sharing Statement

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A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

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