Clinical trial NCT00159497: Bone Remodeling Around HA-coated Acetabular Cups.
Official title: Bone Remodeling Around HA-coated Acetabular Cups.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coxarthrosis
Keywords: THA
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Detailed description: This study was designed to investigate the influence of HA-coating on bone remodeling around the cup in cementless THA.

100 patients gave informed consent to participate in a controlled randomized study between porous coated Trilogy® versus Trilogy Calcicoat®. The cup was inserted in press-fit fixation. The femoral component was a cementless porous coated titanium alloy stem (Bi-Metric®), with a modular 28 mm CrCo head. Effect parameters were Harris Hip Score (HHS) and Bone Mineral Density (BMD) determined by DEXA scanning.

Measurements revealed no difference between the two groups after 3 years, neither in clinical outcome nor in terms of periprosthetic bone density. Patients with Body Mass Index above normal regained more bone mineral than patients with normal weight. This finding supports the assumption that load is beneficial to bone remodeling. Advantages of better sealing of the bone-prosthesis interface, preventing polyethylene induced osteolysis, may still be anticipated for the 7 or 12 year follow-up examinations

Eligibility criteria: Inclusion Criteria:

* Patients eligible for cementless THA

Exclusion Criteria:

* Medical conditions interfering with bone metabolism

Primary outcomes:
measure: Changes in bone mineral density around the hip prosthesis, measured by DEXA scanning
timeFrame: 8-12 years
Secondary outcomes:
measure: Changes in hip performance, measured by Harris Hip Score
timeFrame: 8-12 years
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Northern Orthopaedic Division, Klinik Farsoe, Aalborg University Hospital
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Mogens B Laursen, MD
role: PRINCIPAL_INVESTIGATOR
References: