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CompletedNCT00913679Updated Dec 15, 2022

A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty

An interventional study of Surgical approach (ReCap Hip Resurfacing System) in Osteonecrosis, Femoral Neck Fracture and Implant Failure, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 30 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2008, registered Jun 2009).
Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

BACKGROUND:

6700 total hip replacements are performed each year in Denmark due to osteoarthritis. Young patients sustain a substantial risk of early implant failure due to high-activity daily living, and among patients younger than 55 years at surgery 20 percent need revision surgery within ten years. Revision surgery is more complicated than primary surgery and associated with decreased implant longevity due to decreased bone stock. Resurfacing hip arthroplasty (RHA), restores the anatomy of the hip as only the articulating joint surfaces are replaced, and thus more bone is left to ensure a better opportunity of successful revision surgery later on. The clinical midterm evaluation of RHA survival is promising, but two major complications leading to early revision, namely osteonecrosis and femoral neck fracture, has raised concern regarding the influence of surgical technique on the vascularity of the femoral head. RHA is commonly performed through a posterolateral surgical approach. By this technique muscle tendons are spilt resulting in decreased patient mobility for several weeks after surgery, but more importantly, the blood supply is compromised as a large artery has to be ligated. This is speculated to decrease the blood supply to femoral head and neck and thereby increase the risk of osteonecrosis, femoral neck fracture, and implant failure. With a new surgical technique facilitating an anterolateral approach to the hip joint the blood supply is left intact as well as the muscle tendons.

HYPOTHESIS:

An anterolateral surgical approach in resurfacing hip arthroplasty will 1) preserve the blood supply to the femoral head and neck and improve implant longevity, and 2) spare the muscle tendons and ease patient recovery.

METHOD and FACILITIES:

50 patients, aged 30 to 60 years, with osteoarthrosis of the hip will be randomised to a RHA inserted by either an anterolateral or a posterolateral surgical approach. Primary points of evaluation are 1) blood supply to the femoral head and neck measured intraoperatively by Laser Doppler flowmetry and postoperatively by microdialysis established during surgery. Secondary points of evaluation are 1) implant fixation measured by radiostereometric analysis (RSA), and 2) periprosthetic bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA), 3) gait analysis and 4) clinical scores of function, pain and activities of daily living (Harris Hip Score , Visual Analogue Scale).

02

Conditions studied

  • Osteonecrosis
  • Femoral Neck Fracture
  • Implant Failure

Keywords

  • osteonecrosis
  • femoral neck fracture
  • implant fixation
  • implant failure
  • periprosthetic bone mineral density
  • gait function
  • gait analysis
  • patient recovery
03

In context

Osteonecrosis

189 studies on the registry are indexed under Osteonecrosis; 33 are open to participants now.

This study's enrollment of 49 is close to the median of 50 across 99 interventional studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,299 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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;
  • Age 30 to 60 years.

Exclusion 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 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
49 participants (actual)

Study arms

  • Active comparator
    Posterior approach

    Posterior surgical approach in hip resurfacing arthroplasty

    Procedure: Surgical approach (ReCap Hip Resurfacing System)

  • Active comparator
    Anterolateral approach

    Anterolateral surgical approach in hip resurfacing arthroplasty

    Procedure: Surgical approach (ReCap Hip Resurfacing System)

Interventions

  • ProcedureSurgical approach (ReCap Hip Resurfacing System)

    two different surgical approaches in hip resurfacing arthroplasty

    Also known as: ReCap Hip Resurfacing System

06

What researchers measure

Primary outcomes

  1. femoral head blood flow, evaluated by Laser Doppler Flowmetry

    Time frame: during surgery

  2. femoral head metabolism, evaluated by microdialysis

    Time frame: 3 days

Secondary outcomes

  1. implant fixation, evaluated by RSA (radiostereogrammetric analysis)

    Time frame: postoperatively; 3 months; 1,2 and 5 years

  2. periprosthetic bone mineral density, evaluated by DEXA

    Time frame: pre- and postoperatively; 1 and 2 years

  3. gait function, evaluated by gait analysis

    Time frame: preoperatively; 3 months and 1 year

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

    Time frame: preoperatively and 3 months

07

Study locations

1 site
  • Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2
    Aarhus C, Aarhus County 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 36422666 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00913679
Responsible party
Sponsor
First posted
Jun 4, 2009
Start date
Nov 1, 2008
Primary completion
Feb 20, 2017
Completion
Nov 2020
Last update
Dec 15, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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