NCT00603395

Brief Summary

This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2007

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

8 years

First QC Date

December 23, 2007

Last Update Submit

May 15, 2014

Conditions

ArthritisAvascular Necrosis

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score, Device Revision/Removal, Radiographic Evaluation

    2 years postoperative

Secondary Outcomes (1)

  • Complications

    Anytime

Study Arms (1)

ReCap

OTHER

ReCap Total Hip Resurfacing System

Device: ReCap Total Hip Resurfacing System

Interventions

ReCap Total Hip Resurfacing SystemDEVICE

This is a hip resurfacing system.

ReCap

Eligibility Criteria

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

You may qualify if:

  • intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
  • Osteoarthritis
  • Avascular necrosis
  • Traumatic arthritis
  • Legg Perthes
  • Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Knowledge Center for Orthopedic Surgery, St. Anna hospital

Geldrop, Netherlands

Location

Related Publications (1)

  • van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.

    PMID: 23234268DERIVED

MeSH Terms

Conditions

ArthritisOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • H J Hoekstra, MD

    St. Anna hospital, Geldrop

    PRINCIPAL INVESTIGATOR

  • T Sybesma, PhD

    St. Anna hospital, Geldrop

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 23, 2007

First Posted

January 29, 2008

Study Start

September 1, 2004

Primary Completion

September 1, 2012

Study Completion

May 1, 2014

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

NL(1)