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Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial A prospective blinded randomised controlled multicentre trial comparing the CFP stem with straight stem total hip arthroplasties for the treatment of primary osteoarthritis of the hip.

Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial A prospective blinded randomised controlled multicentre trial comparing the CFP stem with straight stem total hip arthroplasties for the treatment of primary osteoarthritis of the hip. - CUSTOM trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35432
Enrollment
150
Registered
2008-09-16
Start date
2009-08-17
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

osteoarthritis of the hip

Interventions

1. Collum Femoris Preserving Stem 2. Straight stem total hip arthroplasty (such as the Zweymuller) both groups: Trabecular Oriented Pattern (T.O.P.) cup

Sponsors

Onze Lieve Vrouwe Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Male or female being 18 years or older • Patients meet the criteria for osteoarthritis: -Pain in hip -Arthritic changes on radiograph: joint space narrowing femoral / acetabular osteofytes, cysts and signs of sclerosis • Patients not responding to conservative therapy • Written informed consent for study participation

Exclusion criteria

Exclusion criteria: • Patients who are mentally impaired and not able to fill out questionnaires • Patients who have previously received a THA on the contralateral hip. • Patients who do not know the Dutch, or English or German language • Patients with a BMI of more than 40 • Patients with skeletal immaturity • Patients with a life expectancy of less than 3 years • Patients with altered anatomy resulting in impossibility for the CFP procedure, according to the surgeon e.g.: -hip dysplasia with high luxation -post traumatic severe anatomy change -post correction osteotomy • Patients with extremity amputation • Patients with an active malignant disease or current cytostatic treatment • Patients who are participating in another trial • Known alcohol or drug abuse • Any condition that would impede measurement of efficacy to the opinion of the surgeon • Patients with a previous contralateral hip arthroplasty • Patients with avascular head necrosis resulting from sickelcel anemia

Design outcomes

Primary

MeasureTime frame
The Dutch, English and the German version of the Hip disability and Osteoarthritis Outcome Score (HOOS) will be our primary endpoint

Secondary

MeasureTime frame
Hb drop perioperatively Trendelenburg test Timed Up and Go complications Pain on a Numeric Rating Scale (NRS) use of analgesics (5 point Likert scale) satisfaction wound aspect SF-12 (health related quality of life) EQ-5D Harris Hip Score position of the prosthesis migration osteolysis radiolucency

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)