NCT00604734

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
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

October 1, 2004

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months 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 30, 2008

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

December 23, 2007

Last Update Submit

February 7, 2019

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.

Also known as: Total hip resurfacing, ReCap
ReCap

Eligibility Criteria

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

You may qualify if:

  • Patients with a preoperative Total Harris Hip Score of \< 70
  • Conservative treatment has proven unsuccessful
  • Primary hip surgery
  • Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
  • Osteoarthritis
  • Avascular necrosis
  • Legg Perthes
  • Rheumatoid Arthritis
  • Juvenile Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Developmental Dysplasia, which does not prevent stable acetabular reconstruction
  • Post traumatic arthritis S. Patients at least 18 years of age
  • \. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form

You may not qualify if:

  • Patients with a preoperative Total Harris Hip Score of \> 70
  • Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
  • Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
  • Developmental dysplasla, which prevents stable acetabular reconstruction
  • Patients with previous Girdlestone procedures
  • Patients with above knee amputation of the contralateral and/or ipsilateral leg
  • Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
  • Active or suspected systemic or localized Infection
  • Parkinson's or Alzheimer's Disease
  • Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
  • Patients less than 18 years of age
  • Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
  • Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
  • Patients with a "fused"hip
  • Patients with metal allergy or hypersensitivity
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Az Nikolaas Campus Sint Niklaas

Sint-Niklaas, Belgium

Location

MeSH Terms

Conditions

ArthritisOsteonecrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jo De Schepper, MD

    AZ Nikolaas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2007

First Posted

January 30, 2008

Study Start

October 1, 2004

Primary Completion

October 1, 2007

Study Completion

October 1, 2012

Last Updated

February 11, 2019

Record last verified: 2019-02

Locations

BE(1)