NCT02288117

Brief Summary

The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions. The results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
3 countries

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

November 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

December 19, 2020

Status Verified

December 1, 2020

Enrollment Period

6.8 years

First QC Date

November 6, 2014

Last Update Submit

December 16, 2020

Conditions

Osteoarthritis, HipFemur Head NecrosisFemoral Neck Fractures

Keywords

PMCFPost Market Clinical Follow upSP-CLanatomic stem

Outcome Measures

Primary Outcomes (1)

  • Stem Survival Rate

    The survival of the stem

    Up to 5 years

Secondary Outcomes (6)

  • Complication Rate

    Up to 5 years

  • Reoperation Rate

    Up to 5 years

  • Harris Hip Score (HHS)

    Up to 5 years

  • Oxford Hip Score (OHS)

    Up to 5 years

  • Forgotten Joint Score (FJS)

    Up to 2 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mobility-limiting disease, fracture or defect of the hip joint requiring primary THA with SP-CL® (i.e. primary or secondary coxarthrosis, osteoarthritis, femoral neck fracture, necrosis of the femoral head) ·

You may qualify if:

  • Skeletally mature
  • Subject agrees to comply with the required postoperative management and follow-up evaluations
  • Undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment
  • Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
  • Patient signed Informed Consent.

You may not qualify if:

  • Body Mass Index (BMI) \> 40 kg/m2
  • Poor general state of health
  • Acute and chronic infections, local and systemic
  • Pharmaceutical or other drug abuse, alcoholism
  • Allergies to implant materials
  • Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
  • Insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis
  • Severe osteoporosis
  • Foreseeable overload/ overstressing of the joint prosthesis
  • Acetabular defects
  • Female patient who is pregnant or plans to became pregnant during the course of the study
  • Prisoner
  • Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
  • Patient who has not signed the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Krankenhaus Barmherzige Brüder Regensburg

Regensburg, Bavaria, 93049, Germany

Location

HELIOS ENDO-Klinik

Hamburg, 22767, Germany

Location

L'Istituto Ortopedico Gaetano Pini

Milan, 1-20122, Italy

Location

Hospital Sant Rafael

Barcelona, 08035, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, HipFemur Head NecrosisFemoral Neck Fractures

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesOsteonecrosisBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Thorsten Gehrke, Prof. Dr.

    HELIOS Endo-Klinik Hamburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 11, 2014

Study Start

July 1, 2015

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

December 19, 2020

Record last verified: 2020-12

Locations

DE(2)IT(1)ES(1)