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Completed

NCT Number: NCT02447653

Hydroxyapatite (HA) Coating Versus Plasma Porous Spray (PPS) in Press-fit Acetabular Components Early Outcomes With DEXA

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 .

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients requiring total hip replacement surgery for a fresh hip fracture.
  • Patients with inflammatory arthritis
  • 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.
  • 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.
  • 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.

Treatment and study plan

G7 HA Acetabular Component

Device

G7 HA Acetabular Component

G7 PPS Acetabular Component

Device

G7 PPS Acetabular Component

Primary outcomes

  1. Bone Remodelling (DEXA analysis)

    Time frame: 12 months

    DEXA analysis

Secondary outcomes

  1. Clinical (Harris Hip Score)

    Time frame: 24 months

    Harris Hip Score

  2. Clinical (Oxford Hip Score)

    Time frame: 24 months

    Oxford Hip Score

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 19, 2015
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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