NCT00319124

Brief Summary

To identify differences between patients with OA of the hip in an early stage and a healthy control group. Hypothesis 1.1 There are significant differences between patients with OA of the hip in an early stage and a healthy control group in terms of functional capacity, biomechanical / kinematic variables, muscle strength and range of motion. Osteoarthritis (OA) is by far the most prevalent joint disorder today. The knee and the hip are large joints to be targeted and is an important cause of pain and disability. In knee OA, it is shown that significant risk factors in developing the disease are quadriceps weakness, joint instability, and changes in joint loading. A few studies on hip OA have shown altered gait pattern, which affect joint loading, and one study has shown weakness in abductors, adductors and flexors around the hip. As joint loading and muscle weakness are important factors in the development in knee OA, it might as well be factors influencing OA in the hip. The purpose of this case-control studies was to compare hip OA patients to a healthy control group regarding biomechanical and clinical differences. Patients with hip pain, activity limitations (Harris Hip Score 60-95 p) and radiographically verified hip OA was included. The healthy control group will have a Harris Hip Score of 100 p. One hundred and ten patients and fifty controls will be asked to fill in questionnaires on pain, stiffness and physical function (WOMAC), quality-of-life (SF-36 v2), self-efficacy (Lorigue), and activity (PASE) in addition to perform 6-minute walk test, sub-maximal cardiovascular function, strength, and hip range of motion tests. Additionally, Qualisys Pro reflex 3D motion analysis system will be used during walking, one-leg standing, and raising from a chair on a sub-group of 40 patients and 20 controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

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

April 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

March 2, 2016

Status Verified

May 1, 2012

Enrollment Period

3.3 years

First QC Date

April 27, 2006

Last Update Submit

March 1, 2016

Conditions

Keywords

Hip Osteoarthritis, muscle strength, range of motion, aerobic capacity, functional capacity, health-related quality of life

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    Baseline

Secondary Outcomes (7)

  • SF-36 (quality of life)

    Baseline

  • PASE (activity score)

    Baseline

  • muscle strength tests (Cybex 6000)

    Baseline

  • gait analysis (biomechanical analysis)

    Baseline

  • 6 minutes walking test

    Baseline

  • +2 more secondary outcomes

Study Arms (2)

Case

Patients with hip Osteoarthritis

Control

Healthy controls without hip osteoarthritis

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hip osteoarthritis and mild to moderate pain. Matched controls with no hip pain.

You may qualify if:

  • patients between 40 and 80 years old with uni- or bilateral hip disability
  • Harris Hip Score (36) between 60 and 95.Harris Hip score(0-100 points) is widely used as an assessment of hip function in patients with hip OA. Harris Hip Score of 60 or below are used regularly at our institution as one of the criteria for hip surgery (arthroplasty).
  • Patients will be included if they have more than 3 months of hip pain.
  • Patients with radiographic verified hip OA (Danielson's criteria for radiographic OA: Danielsson's criteria for minimal joint space: \<4 mm \<70 years, \<3 mm ≥70 years, or 1 mm difference between hips).
  • Fifty control subjects will have no health problems and no injuries or functional impairment to the lower limbs and will be matched to the patients with OA of the hip by age and gender.

You may not qualify if:

  • Patients have a history of resent trauma or functional impairment to the lower limbs or diseases which might interfere with participation (rheumatoid arthritis, cancer, osteoporosis, severe back pain, knee OA).
  • Patients with co-morbidities not tolerating physical activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NAR- Department of Orthopaedics, Oslo University Hospital & Hjelp24NIMI

Oslo, Oslo County, 0407, Norway

Location

Related Publications (2)

  • Rydevik K, Fernandes L, Nordsletten L, Risberg MA. Functioning and disability in patients with hip osteoarthritis with mild to moderate pain. J Orthop Sports Phys Ther. 2010 Oct;40(10):616-24. doi: 10.2519/jospt.2010.3346.

  • Eitzen I, Fernandes L, Nordsletten L, Risberg MA. Sagittal plane gait characteristics in hip osteoarthritis patients with mild to moderate symptoms compared to healthy controls: a cross-sectional study. BMC Musculoskelet Disord. 2012 Dec 20;13:258. doi: 10.1186/1471-2474-13-258.

Related Links

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • May Arna Risberg, PT,PhD

    NAR-Department of Orthopaedics, Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

April 1, 2005

Primary Completion

August 1, 2008

Study Completion

October 1, 2010

Last Updated

March 2, 2016

Record last verified: 2012-05

Locations