AzTrials
AzTrials

Complications ArthroplastyNCT03031964

Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup

An observational study of Complications Arthroplasty, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Complications Arthroplasty
What is being tested?
revision multihole acetabular cup
Type of treatment
Medical device
How many people
24 participants
Where
1 siteUnited States
Study dates
Dec 2016to Jan 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients requiring a revision total hip arthroplasty

Who may be able to join

  • Patients requiring revision total hip replacement of the acetabular component or complicated primary total hip replacement.
  • Femoral stem (either retained or replaced) is a compatible Stryker stem.
  • Patient is willing to comply with follow-up requirements (e.g. will return for long-term follow-up visits)
  • Age: 18-85 years

Who cannot join

  • Patient has a BMI > 40
  • Exclude revision for infection
  • Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery
  • Patient has history of radiation therapy
  • Patient has known diagnosis of renal disease
  • Patient has known diagnosis of osteoporosis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup

This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.

Read the detailed description

Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4 weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at each site will identify, recruit, and prospectively follow the 60 patients at his/her site. Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for revision, Paprosky classification, native femoral head measurement (mm) etc. will be collected preoperatively. The study coordinator will contact patients prior to each visit to ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition, patients will be assessed for any complications (e.g., dislocation, emergency department visits, infection, reoperation, etc.). Patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific question regarding groin pain) and a pain assessment. In the event that a patient has relocated and/or refuses to return to the office for the 5-year visit, a script will be sent to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All data will be entered and maintained in RedCap.

Being tested
revision multihole acetabular cup

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • revision multihole acetabular cupDevice

    Also called Stryker restoration anatomic shell

    post market study of multi hole revision acetabular cup

Study groups in NCT03031964
Study groupRoleWhat they receive
revision multihole acetabular cupRevision total hip arthroplasty using multihole revision acetabular cup
Receives: Device: revision multihole acetabular cup

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. survivorship of a multihole revision acetabular cup

    evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis

    Measured: 10 years

Secondary outcomes (3)

  1. Clinical outcomes of multihole revision acetabular cup

    determine clinical outcomes with VR-12 surveys

    Measured: 10 years

  2. functional outcomes of multihole revision acetabular cup

    determine functional outcomes with HOOS surveys

    Measured: 10 years

  3. assess pain levels in patients who receive multihole revision acetabular cup

    determine level of pain with pain assessments

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completionJan 2022
  4. Study completionJan 2022

Why it stopped: Closed the single investigator initiated study at request of Stryker, to begin collecting as a multicenter study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03031964
Sponsor's protocol ID
#16-1030
Status last verified
Jan 2022
First submitted
20 Dec 2016
Last updated
28 Jan 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Jafari SM, Bender B, Coyle C, Parvizi J, Sharkey PF, Hozack WJ. Do tantalum and titanium cups show similar results in revision hip arthroplasty? Clin Orthop Relat Res. 2010 Feb;468(2):459-65. doi: 10.1007/s11999-009-1090-5.

    PubMed 19809857

  • Kremers HM, Howard JL, Loechler Y, Schleck CD, Harmsen WS, Berry DJ, Cabanela ME, Hanssen AD, Pagnano MW, Trousdale RT, Lewallen DG. Comparative long-term survivorship of uncemented acetabular components in revision total hip arthroplasty. J Bone Joint Surg Am. 2012 Jun 20;94(12):e82. doi: 10.2106/JBJS.K.00549.

    PubMed 22717834

  • Unger AS, Lewis RJ, Gruen T. Evaluation of a porous tantalum uncemented acetabular cup in revision total hip arthroplasty: clinical and radiological results of 60 hips. J Arthroplasty. 2005 Dec;20(8):1002-9. doi: 10.1016/j.arth.2005.01.023.

    PubMed 16376255

  • Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.

    PubMed 23927907

  • Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

    PubMed 17403800

  • Silverton CD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision total hip arthroplasty using a cementless acetabular component. Technique and results. Clin Orthop Relat Res. 1995 Oct;(319):201-8.

    PubMed 7554631

  • Petrera P, Rubash HE. Revision Total Hip Arthroplasty: The Acetabular Component. J Am Acad Orthop Surg. 1995 Jan;3(1):15-21. doi: 10.5435/00124635-199501000-00003.

    PubMed 10790649

  • Klika AK, Murray TG, Darwiche H, Barsoum WK. Options for acetabular fixation surfaces. J Long Term Eff Med Implants. 2007;17(3):187-92. doi: 10.1615/jlongtermeffmedimplants.v17.i3.20.

    PubMed 19023943

  • Ramappa M, Bajwa A, Kulkarni A, McMurtry I, Port A. Early results of a new highly porous modular acetabular cup in revision arthroplasty. Hip Int. 2009 Jul-Sep;19(3):239-44. doi: 10.1177/112070000901900309.

    PubMed 19876878

  • Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. Bone response to a novel highly porous surface in a canine implantable chamber. J Biomed Mater Res B Appl Biomater. 2004 Nov 15;71(2):387-91. doi: 10.1002/jbm.b.30104.

    PubMed 15389510

  • Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x.

    PubMed 8163974

  • Claus AM, Engh CA Jr, Sychterz CJ, Xenos JS, Orishimo KF, Engh CA Sr. Radiographic definition of pelvic osteolysis following total hip arthroplasty. J Bone Joint Surg Am. 2003 Aug;85(8):1519-26. doi: 10.2106/00004623-200308000-00013.

    PubMed 12925632

Questions about this trial

What is this clinical trial studying?

An observational study of Complications Arthroplasty, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Closed the single investigator initiated study at request of Stryker, to begin collecting as a multicenter study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survivorship of a multihole revision acetabular cup (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03031964, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in