Clinical trial NCT02447653: Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA
Official title: A Randomised Controlled Study Comparing Hydroxyapatite (HA) Coating Versus Plasma Porous Spray in Press-fit Acetabular Components Early Outcomes With Dual Energy X-ray Absorptiometry (DEXA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-05-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density. Clinical evaluations will be conducted .

Detailed description: The study design comprises a randomized trial of patients undergoing primary total hip arthroplasty using the G7 acetabular system and Taperloc Complete stem comparing regular plasma porous spray with HA coating using Bonemaster (BM) in an uncemented cup. DEXA scanning will be used to measure periprosthetic bone mineral density preoperatively and post-operatively at 6 weeks, 12 weeks, 26 weeks, and 12 months for both the treated and contralateral hip joint. Clinical evaluations will be conducted preoperatively, and postoperatively at 6, 12, 26 weeks, 12 months and 24 months.

Eligibility criteria: Inclusion Criteria:

1. Patients with osteoarthritis who are candidates for a primary total hip replacement with uncemented acetabular and femoral components as determined by the surgeon.
2. Male and non-pregnant female patient aged 18 to 70.
3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion Criteria:

1. Patients requiring total hip replacement surgery for a fresh hip fracture.
2. Patients with inflammatory arthritis
3. Patients with metabolic bone disease or taking drugs that affect bone turnover. 4 .Patients requiring revision surgery of a previously implanted total hip replacement system or patients requiring a conversion surgery from a previous fracture fixation or hip fusion.

5. Patients with presence of malignancy in the area of the involved hip joint. 6. Patients who, as judged by the surgeon, are mentally incompetent or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.

7. Patients with other concurrent illnesses that are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.

Primary outcomes:
measure: Bone Remodelling (DEXA analysis)
timeFrame: 12 months
Secondary outcomes:
measure: Clinical (Harris Hip Score)
timeFrame: 24 months
measure: Clinical (Oxford Hip Score)
timeFrame: 24 months
Other outcomes:
Locations:
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
Study officials:
affiliation: Gold Coast Centre for Bone and Joint Surgery
name: David Liu
role: PRINCIPAL_INVESTIGATOR
References: