NCT02237482

Brief Summary

This study is intended to compare the proximal migration of the tantalum design (TM) with a cemented cup used in conjunction with bone allografting in cases with major bone loss. A group of patients with good periacetabular bone stock are included to analyse the differences between the tantalum and titanium design regarding risk of loosening and differences in clinical outcome measures. Radiostereometry (RSA) is used to accurately measure migration and rotation of the revision cups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
Last Updated

September 12, 2014

Status Verified

September 1, 2014

Enrollment Period

5.4 years

First QC Date

September 4, 2014

Last Update Submit

September 10, 2014

Conditions

Prosthesis Loosening

Outcome Measures

Primary Outcomes (1)

  • Proximal migration measured with RSA

    All patients have been recruited (operated on) by end of December 2011. Our primary intention is to follow all patients a minimum of two years with RSA.

    24 month postoperatively.

Secondary Outcomes (1)

  • Patient reported outcome measures

    first two years postoperatively

Other Outcomes (2)

  • Re-revision due to aseptic loosening or radiographical loosening

    minimum13 years postoperative

  • EuroQol 5D

    first two years postoperatively.

Study Arms (2)

Small periacetabular bone defects

EXPERIMENTAL

Patients with cup loosening and small periacetabular bone defects

Device: Trilogy cupDevice: Trabecular metal cup (TM)

Large periacetabular bone defects

EXPERIMENTAL

Patients with cup loosening and large periacetabular bone defects

Device: Trabecular metal cup (TM)Device: ZCA cup

Interventions

Trilogy cupDEVICE
Small periacetabular bone defects
Trabecular metal cup (TM)DEVICE
Large periacetabular bone defectsSmall periacetabular bone defects
ZCA cupDEVICE
Large periacetabular bone defects

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with a loose acetabular component, undergoing revision

You may not qualify if:

  • Patient not able to understand the intention of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (4)

  • Borlin N, Rohrl SM, Bragdon CR. RSA wear measurements with or without markers in total hip arthroplasty. J Biomech. 2006;39(9):1641-50. doi: 10.1016/j.jbiomech.2005.05.004. Epub 2005 Jun 28.

    PMID: 15990104BACKGROUND

  • Cuckler JM. Management strategies for acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2002 Jun;17(4 Suppl 1):153-6. doi: 10.1054/arth.2002.32811.

    PMID: 12068428BACKGROUND

  • Lakstein D, Backstein D, Safir O, Kosashvili Y, Gross AE. Trabecular Metal cups for acetabular defects with 50% or less host bone contact. Clin Orthop Relat Res. 2009 Sep;467(9):2318-24. doi: 10.1007/s11999-009-0772-3. Epub 2009 Mar 10.

    PMID: 19277803BACKGROUND

  • Schreurs BW, Keurentjes JC, Gardeniers JW, Verdonschot N, Slooff TJ, Veth RP. Acetabular revision with impacted morsellised cancellous bone grafting and a cemented acetabular component: a 20- to 25-year follow-up. J Bone Joint Surg Br. 2009 Sep;91(9):1148-53. doi: 10.1302/0301-620X.91B9.21750.

    PMID: 19721038BACKGROUND

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johan Kärrholm, Professor

    Sahlgrenska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 11, 2014

Study Start

July 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 12, 2014

Record last verified: 2014-09

Locations

SE(1)