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Activity levels in young patients with cemented total hip arthroplasty: a prospective observational actigraphic study


- candidate number3863
- NTR NumberNTR1418
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-aug-2008
- Secondary IDsUMCN-2008 St Radboud
- Public TitleActivity levels in young patients with cemented total hip arthroplasty: a prospective observational actigraphic study
- Scientific TitleActivity levels in young patients with cemented total hip arthroplasty: a prospective observational actigraphic study
- ACRONYMACTI-HIP
- hypothesisThe outcome of primary cemented total hip arthroplasty in young patients under 50-years implanted at our Department shows promising long-term prosthesis survival rates. However, many young patients have already an acetabular bone stock deficiency at surgery and they are the more demanding hips. In case of acetabular deficiency, these defects are reconstructed with impacted bone-grafts. Total hip arthroplasty with impacted bone grafts showed a tendency to even better long-term survival rates than hip arthroplasty without acetabular bone reconstruction, which is remarkable. Insight into the level of activity is necessary to determine if these good results are related to lower activity levels in the acetabular reconstruction group or related to the acetabular bone-grafting technique.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hip diseases, Physical activity, Arthroplasty , Actometer
- Inclusion criteriaPatients:
1. Primary cemented total hip arthroplasty
2. Surgery at the Radboud University Nijmegen Medical Centre
3. Operated between 1988 and 2004
4. Younger than 50 years at time of hip surgery
5. Reconstructed with or without acetabular bone reconstruction

Controls:
1. Similar age ( 5 years) and gender
- Exclusion criteria1. Revision of primary hip prosthesis
2. Not able to walk
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2008
- planned closingdate1-sep-2010
- Target number of participants120
- InterventionsProspective observational cohort study to determine activity levels in young primary cemented total hip arthroplasty patients under 50-years
- Primary outcomeThe general average physical activity score, derived from the Actometer- data, and determined by the number of accelerations per 5-min periods will be determined during a 14-days period.
- Secondary outcomeSelf-reported daily Activity, Pain and Fatigue severity
- Timepoints14-days period
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Brunnekreef
- CONTACT for SCIENTIFIC QUERIES B.W. Schreurs
- Sponsor/Initiator Radboud University Nijmegen Medical Centre, Department of Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Centre Nijmegen
- PublicationsN/A
- Brief summaryTotal hip arthroplasty with impacted bone grafts show a tendency for better long-term prosthesis survival than hip arthroplasty patients without acetabular bone reconstruction. To determine whether activity levels play a role in prosthesis survival, a prospective observational cohort study was designed to determine activity levels in young primary cemented total hip arthroplasty patients under 50-years.
Physical activity levels are determined by actometer-data obtained during a 14-day period and by self-reported daily Activity, Pain and Fatigue severity questionnaire.
- Main changes (audit trail)
- RECORD22-aug-2008 - 12-nov-2008


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