A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing - Full Text View

Purpose

This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.

Condition	Intervention	Phase
Arthritis Avascular Necrosis	Procedure: Anterolateral approach Procedure: Posterior approach	Phase IV

MedlinePlus related topics:

Osteonecrosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Official Title:	A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

RSA [ Time Frame: 1 week, 3 months, 1 year, 2 years, 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Harris Hip Score [ Time Frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year ] [ Designated as safety issue: No ]
Microdialysis [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Conventional X-ray [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Gait Analysis [ Time Frame: 1 week, 3 months, 1 year ] [ Designated as safety issue: No ]
DEXA scan [ Time Frame: Pre-operatively, 1 week, 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.	Procedure: Anterolateral approach 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.
2: Active Comparator This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.	Procedure: Posterior approach 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.

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.

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750984

Contacts


Contact: David Stephenson	+44 1793 645 229	david.stephenson@biometeurope.com

Locations


Denmark
	Aarhus University Hospital	Recruiting
	Arhus, Denmark
	Contact: Kjeld Soballe, MD, PhD (+45) 89497425 kjeld.soeballe@as.aaa.dk
	Contact: Thomas Pryno, MD pryno@as.aaa.dk
	Principal Investigator: Thomas Pryno, MD
	Principal Investigator: Kjeld Soballe, MD, PhD

Sponsors and Collaborators

Biomet U.K. Ltd.

Investigators

More Information

Responsible Party:	Biomet U.K. Ltd. ( David Stephenson, Director of Clinical Research )
Study ID Numbers:	EU9
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00750984
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Study placed in the following topic categories:

Necrosis

Musculoskeletal Diseases

Osteonecrosis

Joint Diseases

Arthritis

Bone Diseases

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Biomet U.K. Ltd.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00750984