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Bone Impaction grafting vs standard fixationtechnique of the acetabular cup in total hip arthroplasty in patients under 60.

Bone Impaction grafting vs standard fixationtechnique of the acetabular cup in total hip arthroplasty in patients under 60. - BIG-trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36900
Enrollment
132
Registered
2012-10-23
Start date
2012-12-07
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

degenerative hip disease osteoarthritis of the hip

Interventions

Surgery will be conducted by the orthopedic dept of the Isala Clinics Zwolle. A total of 132 patients will have THA of which 66 will have a standard fixation technique and 66 will have BIG technique

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent 2. Age between 18 and 60 years 3. Mentally competent men and women with debilitating osteoarthritis of the hip indicated for a total hip arthroplasty

Exclusion criteria

Exclusion criteria: 1. BMI > 35 2. Previous ipsilateral hipsurgery 3. Contralateral debilitating osteoarthritis of the hip 4. Acetabular defects wherefore BIG indicated: - AAOS type 1-5 defect - Acetabular fracture with more than 2 mm dislocation - DDH with CE angle 2 cm 5. Rheumatoïd Arthritis (RA) 6. Hip dislocation 7. Malignancy 8. Standard contraindications, as prevailing for elective total hip arthroplasty (pregnancy, infection and severe comorbidity of pulmonary, cardiac or metabolic nature)

Design outcomes

Primary

MeasureTime frame
Patient satisfaction with HOOS-functioning in daily live subscale 1 year post-surgery is primairy outcome. The definition of succes (non-inferiority) for the individual patient is as follows: a clinical non-relevant difference is defined as 9 points or less on the HOOS functioning in daily life subscale.

Secondary

MeasureTime frame
Besides the other 4 HOOS subscales and the HOOS total score, the following secundary outcomes will be used to evaluate effectivity of both fixationtechniques: - VAS pain and VAS satisfaction - SF 36 - Clinical data: Bloodloss, surgery time, length of hospital stay - Radiological - X-ray: version and inclination cup - Complications: bleeding, infection, dislocation, meralgia paraesthetica, venous thromboembolism and loosening Simultanously course in time of HOOS, VAS, SF 36 will be analyzed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)