NCT02311179

Brief Summary

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

November 22, 2023

Status Verified

December 1, 2022

Enrollment Period

2.2 years

First QC Date

November 6, 2012

Last Update Submit

November 21, 2023

Conditions

Osteoarthritis

Keywords

Prosthesis fixationhip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA)

    End of study (up to 5 years)

Secondary Outcomes (8)

  • Reoperation of affected hips

    End of study (up to 5 years)

  • Postoperative complications (up to 5 years)

    End of study

  • HOOS (Hip disability and osteoarthritis outcome score)

    End of study (up to 5 years)

  • OHS (Oxford Hip Score)

    End of study (up to 5 years)

  • HHS (Harris Hip Score) on Range Of Motion (ROM)

    End of study (up to 5 years)

  • +3 more secondary outcomes

Study Arms (2)

Prosthesis, BoneMaster-Exceed cup

ACTIVE COMPARATOR

Prosthesis, BoneMaster-Exceed cup: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster)

Device: Prosthesis, BoneMaster-Exceed cup (Biomet)

Prosthesis Exceed cup without HA

ACTIVE COMPARATOR

Prosthesis Exceed cup without HA: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray

Device: Prosthesis Exceed cup without HA (Biomet)

Interventions

Prosthesis, BoneMaster-Exceed cup (Biomet)DEVICE

Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.

Prosthesis, BoneMaster-Exceed cup
Prosthesis Exceed cup without HA (Biomet)DEVICE

Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.

Prosthesis Exceed cup without HA

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic radiographic osteoarthritis
  • Radiographically and clinically adequate bone quality with regard to a total hip prosthesis, including osteoporosis-Dexa-Scanning verification.
  • Age 55 to 75 years
  • Informed written consent

You may not qualify if:

  • Orthopaedic
  • Neuromuscular or vascular condition in one or the other lower extremity
  • Immobilization postoperative for long periods, for instance because of other serious diseases, alloplasties of the other lower-extremity joint, etc (decided by investigator)
  • Reoperation of affected hip because of 4.1 luxation (with closed or open reduction) 4.2 deep infection 4.3 fracture 4.4 aseptic loosening 4.5 other
  • Insufficient RSA marker spread or rigidity Operative
  • Use of component other than Bimetric femoral stem (HA porous-coated without collar)
  • Unsuitable bone quality for uncemented hip alloplasty, evaluated preoperatively
  • Complications peroperatively on insertion of hip alloplasty that necessitate deviation for the described operative procedure (see section: "Operative procedure"), among others 9.1 per- and postoperative fracture 9.2 bone graft used peroperatively (treatment of bone defects, cysts, etc.) 9.3 screw fixation of the acetabulum 9.4 gluteal detachment or extensive femoral exposure 9.5 trochanter osteotomy 9.6 Under-reaming 1-2 mm (cup size is one mm larger than the reamer, i.e. reaming 51 mm, cup 52 mm) 9.7 Other Radiographic
  • Cup placement 10.1 Cup inclination in AP (anteroposterior) plan \>56 degrees and \<35 degrees as evaluated on roentgenogram Medical
  • Arthritis 12.1. rheumatoid arthritis 12.2. psoriasis arthritis 12.3. other arthritides
  • Metabolic bone disease 13.1. hyperparathyroidism 13.2. Paget bone disease 13.3. renal osteodystrophy 13.4. other
  • Reduced kidney function thereby influencing bone metabolism
  • Previous treatment of skeleton with radiation therapy
  • Cancer Pharmaceuticals
  • Pharmaceuticals that effect calcium-phosphorus metabolism and bone density 87-98, either through intermittent administration or as a constant dose 17.1. glucocorticoids (systemic) beyond short-term treatment (\<5 days) 17.2. immunosuppression/modulation (cyclosporine, methotrexate, etc.) Compliance related
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

    PMID: 36422666DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Prostheses and Implants

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Kjeld Soballe, Prof, dr med

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2012

First Posted

December 8, 2014

Study Start

January 1, 2013

Primary Completion

March 1, 2015

Study Completion

August 1, 2024

Last Updated

November 22, 2023

Record last verified: 2022-12

Locations

DK(1)