Improvement of Implant Survival in Total Joint Arthroplas... | NCT01554748

Studies
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

NCT01554748

Sponsor

Regional Hospital Holstebro

Status

Unknown status

Last Update Posted

Feb 13, 2020Actual

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Total joint arthroplasty

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2023Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Mar 12, 2012

First Submission Date that Met QC Criteria

Mar 13, 2012

First Posted Date

Mar 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2020

Last Update Posted Date

Feb 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Torben B. Hansen, Professor, MD, PhD, Regional Hospital HolstebroPrincipal Investigator

Lead Sponsor

Regional Hospital HolstebroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.

Detailed Description

The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient cohort	Other	TMC total joint arthroplasty	Procedure: Total joint arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total joint arthroplasty	Procedure		Patient cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implant survival	Revision with removal of implant	10 year survival

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

Patients with Eaton type 4 TMC osteoarthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torben B. Hansen, MD, PhD	Orthopaedic Research Unit Regional Hospital Holstebro	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Orthopaedics, Regional Hospital Holstebro	Recruiting	Holstebro		DK-7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32228611	Derived	Mosegaard SB, Stilling M, Hansen TB. Risk factors for limited improvement after total trapeziometacarpal joint arthroplasty. Health Qual Life Outcomes. 2020 Mar 30;18(1):90. doi: 10.1186/s12955-020-01333-z.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures