Osteoarthritis, HipNCT02288117
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
An observational study of Osteoarthritis, Hip and Femur Head Necrosis, run by Waldemar Link GmbH & Co. KG at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
- How many people
- 240 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Jul 2015to May 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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) ·
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
HELIOS ENDO-Klinik
Hamburg, 22767
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, 93049
About this study
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.
Read the detailed description
Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions [2,3]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.
- Keywords
- PMCF, Post Market Clinical Follow up, SP-CL, anatomic stem
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem Survival Rate
The survival of the stem
Measured: Up to 5 years
Secondary outcomes (6)
Complication Rate
Number and kind of complications
Measured: Up to 5 years
Reoperation Rate
number of reoperations
Measured: Up to 5 years
Harris Hip Score (HHS)
Clinical Score to get information about the subjects pain and hip function, collected continuously
Measured: Up to 5 years
Oxford Hip Score (OHS)
PROM to assess function and pain after THR
Measured: Up to 5 years
Forgotten Joint Score (FJS)
awareness of the artificial joint
Measured: Up to 2 years
Mid Thigh Pain
Pain occuring in the front and mid part of the femur
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startJul 2015
- Primary completionMay 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waldemar Link GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thorsten Gehrke, Prof. Dr., Principal investigator, HELIOS Endo-Klinik Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288117
- Sponsor's protocol ID
- 1202 HP
- Status last verified
- Dec 2020
- First submitted
- 6 Nov 2014
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
- ClinicalTrials.gov ID
- NCT02288117
- Acronym / sponsor ID
- 1202 HP
- Keywords
- PMCF, Post Market Clinical Follow up, SP-CL, anatomic stem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Waldemar Link GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term performance issues under routine conditions [2,3]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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) ·
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stem Survival Rate
Time frame: Up to 5 years
The survival of the stem
6 secondary outcomes
Complication Rate
Time frame: Up to 5 years
Reoperation Rate
Time frame: Up to 5 years
Harris Hip Score (HHS)
Time frame: Up to 5 years
Oxford Hip Score (OHS)
Time frame: Up to 5 years
Forgotten Joint Score (FJS)
Time frame: Up to 2 years
Mid Thigh Pain
Time frame: Up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thorsten Gehrke, Prof. Dr. principal investigator
HELIOS Endo-Klinik Hamburg
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip and Femur Head Necrosis, run by Waldemar Link GmbH & Co. KG at 4 sites in 3 countries.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Italy, Spain. 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?
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?
Stem Survival Rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.