NCT00913679

Brief Summary

The purpose of the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

8.3 years

First QC Date

June 2, 2009

Last Update Submit

December 14, 2022

Conditions

OsteonecrosisFemoral Neck FractureImplant Failure

Keywords

osteonecrosisfemoral neck fractureimplant fixationimplant failureperiprosthetic bone mineral densitygait functiongait analysispatient recovery

Outcome Measures

Primary Outcomes (2)

  • femoral head blood flow, evaluated by Laser Doppler Flowmetry

    during surgery

  • femoral head metabolism, evaluated by microdialysis

    3 days

Secondary Outcomes (4)

  • implant fixation, evaluated by RSA (radiostereogrammetric analysis)

    postoperatively; 3 months; 1,2 and 5 years

  • periprosthetic bone mineral density, evaluated by DEXA

    pre- and postoperatively; 1 and 2 years

  • gait function, evaluated by gait analysis

    preoperatively; 3 months and 1 year

  • patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale

    preoperatively and 3 months

Study Arms (2)

Posterior approach

ACTIVE COMPARATOR

Posterior surgical approach in hip resurfacing arthroplasty

Procedure: Surgical approach (ReCap Hip Resurfacing System)

Anterolateral approach

ACTIVE COMPARATOR

Anterolateral surgical approach in hip resurfacing arthroplasty

Procedure: Surgical approach (ReCap Hip Resurfacing System)

Interventions

Surgical approach (ReCap Hip Resurfacing System)PROCEDURE

two different surgical approaches in hip resurfacing arthroplasty

Also known as: ReCap Hip Resurfacing System
Anterolateral approachPosterior approach

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • Age 30 to 60 years.

You may not qualify if:

  • 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 postoperatively;
  • 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-diuretics;
  • Alcoholism, females over 14 units per week, males over 21 units per week; AVN;
  • Osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2

Aarhus C, Aarhus County, 8000, Denmark

Location

Related Publications (1)

  • Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

    PMID: 36422666DERIVED

MeSH Terms

Conditions

OsteonecrosisFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

November 1, 2008

Primary Completion

February 20, 2017

Study Completion

November 1, 2020

Last Updated

December 15, 2022

Record last verified: 2022-12

Locations

DK(1)