Revision Hip ArthroplastyNCT07653295
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
An observational study of Revision Hip Arthroplasty and Aseptic Loosening of Prosthetic Joint, run by TIPMED Medical Device Manufacturing Ltd. Co. at 4 sites in Turkey (Türkiye).
Trial summary
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections
- What is being tested?
- Tıpmed™ Revision Hip Prosthesis System
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone revision hip arthroplasty (either total revision or partial component revision) due to a documented joint failure or clinical complication at participating multi-center orthopedic clinics. The cohort specifically represents individuals whose surgical treatment involved the standard clinical implantation of the Tıpmed™ Revision Hip Prosthesis System configurations. Participants who are legally competent, free of legal constraints, and provide written informed consent to allow their routine baseline parameters and prospective post-operative clinical, laboratory, and radiographic surveillance data to be documented will be consecutively enrolled.
Who may be able to join
- Individuals aged 18 years and older,
- Male or female participants,
- Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),
- Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components were utilized,
- Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship),
- Participants who have voluntarily signed the written Informed Consent Form (ICF).
Who cannot join
- Subjects currently participating in any other interventional clinical trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
Balıkesir, 10100
Özgün Karakuş, Professor, +90 266 460 4000, ozgunkarakus@hotmail.com
Özgün Karakuş, Professor
- Recruiting
Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
Balıkesir, 10900
Cemal Aydın, MD, Spec., +90 266 412 6999, cemalaydın80@hotmail.com
Cemal Aydın, MD, Spec.
- Recruiting
Dokuz Eylül University Research and Application Hospital
Izmir, 35330
Ahmet Karakaşlı, Professor, +90 (232) 412 22 22, karakasliahmet@gmail.com
Ahmet Karakaşlı, Professor
- Recruiting
Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
Izmir, 35390
Kamil Yamak, Professor, +90 532 722 0852, kamilyamak@hotmail.com
Kamil Yamak, Professor
About this study
Official title: A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
Read the detailed description
This prospective, multi-center, observational, Post-Market Clinical Follow-Up (PMCF) study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Revision Hip Prosthesis System in adult patients undergoing revision hip arthroplasty (total or partial) across participating clinical centers in Turkey. A total of 35 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, comprehensive medical history, previous arthroplasty data, and specific indications for revision surgery (such as aseptic loosening, infection, dislocation, or periprosthetic fractures) will be captured retrospectively from patient medical charts. Following the baseline revision surgical procedure, subjects will undergo a 24-month clinical follow-up period consisting of 6 routine post-operative assessment windows: at 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. At each longitudinal visit, investigators will complete a study-specific Case Report Form (CRF) to document objective clinical and survival indicators. Clinical performance and joint functionality profiles will be quantitatively monitored utilizing the Harris Hip Score (HHS). Safety endpoints will be continuously evaluated by identifying, classifying, and reporting any adverse events (AEs), serious adverse events (SAEs), implant-related complications (including re-revision rates, dislocation, aseptic loosening, infection, or nerve/vascular injuries), and hardware deficiencies. Radiological findings (implant positioning, component orientation, migration, osteointegration, and status of acetabular/femoral bone loss) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.
Demographic characteristics, baseline clinical parameters, and longitudinal efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of revision surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial revision hip arthroplasty to isolate and evaluate their clinical outcomes independently from the patients treated with total revision hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability, Periprosthetic Fractures, Prosthesis Failure
- Being tested
- Tıpmed™ Revision Hip Prosthesis System
- Keywords
- Hip Prosthesis, Revision Hip Arthroplasty, Revision Hip Prosthesis, Post-Market Clinical Follow-Up (PMCF), Harris Hip Score (HHS)
- Medical subject headings
- Joint Instability, Periprosthetic Fractures, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tıpmed™ Revision Hip Prosthesis SystemDevice
Post-market evaluation of the commercially available, CE-marked Tıpmed™ Revision Hip Prosthesis System during routine revision orthopedic care. Surgeon-directed device configurations are utilized based on patient-specific bone loss and anatomy, incorporating various mono-block or modular femoral stems, modular femoral body components, and femoral necks. Acetabular reconstruction elements encompass various configurations including acetabular cups, bipolar cups, and titanium metal shells with modular inserts, paired with dedicated bone-anchoring options such as acetabular rings, reinforcement cages, and anatomical rings based on standard clinical routine. In strict adherence to the prospective observational design of this registry, no investigational, experimental, or non-routine surgical interventions are performed.
| Study group | Role | What they receive |
|---|---|---|
| Tıpmed™ Revision Hip Prosthesis | A single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice. Receives: Device: Tıpmed™ Revision Hip Prosthesis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
The proportion of participants achieving 'Excellent' (≥ 90 points) or 'Good' (80-89 points) clinical performance based on the Harris Hip Score (HHS) will be evaluated to demonstrate device efficacy. The HHS is a clinician-administered tool that quantitatively scores hip function across domains including pain, function, functional activities, absence of deformity, and range of motion (ROM), with a total score ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Measured: 24 months post-operatively
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Continuous monitoring, documentation, and cumulative tracking of the incidence and frequency of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study surveillance period, regardless of their causal relationship to the investigational revision medical device or surgical procedure. Events will be systematically classified by intensity/severity (mild, moderate, severe), outcome characteristics, and causality relationship pattern.
Measured: From the signing of informed consent up to 24 months post-operatively.
Incidence of Clinical Complications
Evaluation of the rate, frequency, and types of all clinical complications recorded throughout the study. This includes intraoperative complications captured retrospectively from surgical medical charts (such as femoral or acetabular perforation/fractures, vascular injuries, and nerve lesions including peroneal or sciatic nerve injuries) as well as longitudinal complications documented during the prospective follow-up phase (such as joint dislocation, aseptic loosening, implant failure/breakage, deep or superficial surgical site infections, and subsequent re-revision/reoperation rates) associated with the routine clinical utilization of the Tıpmed™ Revision Hip Prosthesis System.
Measured: From the time of signing the informed consent form up to 24 months post-operatively.
Secondary outcomes (1)
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Periodic monitoring of absolute HHS tracking metrics and category shifts to determine the prospective trajectory of functional recovery over time. The total HHS ranges from 0 (worst possible outcome) to 100 (best possible outcome) and is categorized as follows: Excellent (90-100); Good (80-89); Fair (70-79); Poor (60-69); and Very Poor (<60). Transition tables will be generated utilizing these classifications to map longitudinal shifts from the retrospectively captured pre-operative baseline value (extracted from patient medical charts) across all prospective post-operative follow-up intervals.
Measured: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start12 Mar 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision Hip ArthroplastyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmet Karakaşlı, Professor, Study director, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653295
- Sponsor's protocol ID
- INFO TPMHIP R
- Other IDs
- 2023-191
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No.6698), and commercial intellectual property rights policies of the sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational, Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision Hip Prosthesis System
- ClinicalTrials.gov ID
- NCT07653295
- Acronym / sponsor ID
- INFO TPMHIP R
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability, Periprosthetic Fractures, Prosthesis Failure
- Keywords
- Hip Prosthesis, Revision Hip Arthroplasty, Revision Hip Prosthesis, Post-Market Clinical Follow-Up (PMCF), Harris Hip Score (HHS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 17 Jun 2026 (actual)
- 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.
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Revision Hip Prosthesis System in adult participants undergoing revision hip arthroplasty. The study aims to gather real-world clinical evidence on the 24-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.
Detailed description
This prospective, multi-center, observational, Post-Market Clinical Follow-Up (PMCF) study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Revision Hip Prosthesis System in adult patients undergoing revision hip arthroplasty (total or partial) across participating clinical centers in Turkey. A total of 35 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, comprehensive medical history, previous arthroplasty data, and specific indications for revision surgery (such as aseptic loosening, infection, dislocation, or periprosthetic fractures) will be captured retrospectively from patient medical charts. Following the baseline revision surgical procedure, subjects will undergo a 24-month clinical follow-up period consisting of 6 routine post-operative assessment windows: at 6 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. At each longitudinal visit, investigators will complete a study-specific Case Report Form (CRF) to document objective clinical and survival indicators. Clinical performance and joint functionality profiles will be quantitatively monitored utilizing the Harris Hip Score (HHS). Safety endpoints will be continuously evaluated by identifying, classifying, and reporting any adverse events (AEs), serious adverse events (SAEs), implant-related complications (including re-revision rates, dislocation, aseptic loosening, infection, or nerve/vascular injuries), and hardware deficiencies. Radiological findings (implant positioning, component orientation, migration, osteointegration, and status of acetabular/femoral bone loss) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.
Demographic characteristics, baseline clinical parameters, and longitudinal efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of revision surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial revision hip arthroplasty to isolate and evaluate their clinical outcomes independently from the patients treated with total revision hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tıpmed™ Revision Hip Prosthesis | – | Device: Tıpmed™ Revision Hip Prosthesis SystemA single prospective, multi-center, non-interventional cohort of adult patients tracked during routine clinical practice who have undergone revision hip arthroplasty using the Tıpmed™ Revision Hip Prosthesis System. Patients are enrolled following revision surgery indicated for clinical complications such as aseptic loosening, periprosthetic infection, joint instability, dislocation, or periprosthetic fractures. The cohort captures real-world clinical data based on standard orthopedic indications without any study-mandated modifications to the routine surgical choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult patients aged 18 years and older, of both sexes, who have undergone revision hip arthroplasty (either total revision or partial component revision) due to a documented joint failure or clinical complication at participating multi-center orthopedic clinics. The cohort specifically represents individuals whose surgical treatment involved the standard clinical implantation of the Tıpmed™ Revision Hip Prosthesis System configurations. Participants who are legally competent, free of legal constraints, and provide written informed consent to allow their routine baseline parameters and prospective post-operative clinical, laboratory, and radiographic surveillance data to be documented will be consecutively enrolled.
Key inclusion criteria (6 listed)
- Individuals aged 18 years and older,
- Male or female participants,
- Participants who have undergone Revision Hip Arthroplasty (either total revision or partial component revision) for any indication (such as a documented joint failure or prosthesis-related clinical complication),
- Participants in whose revision procedure the Tıpmed™ Revision Hip Prosthesis System components were utilized,
- Participants who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship),
Key exclusion criteria (1 listed)
- Subjects currently participating in any other interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tıpmed™ Revision Hip Prosthesis SystemPost-market evaluation of the commercially available, CE-marked Tıpmed™ Revision Hip Prosthesis System during routine revision orthopedic care. Surgeon-directed device configurations are utilized based on patient-specific bone loss and anatomy, incorporating various mono-block or modular femoral stems, modular femoral body components, and femoral necks. Acetabular reconstruction elements encompass various configurations including acetabular cups, bipolar cups, and titanium metal shells with modular inserts, paired with dedicated bone-anchoring options such as acetabular rings, reinforcement cages, and anatomical rings based on standard clinical routine. In strict adherence to the prospective observational design of this registry, no investigational, experimental, or non-routine surgical interventions are performed. | Device | Tıpmed™ Revision Hip Prosthesis |
Primary outcome
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months
Time frame: 24 months post-operatively
The proportion of participants achieving 'Excellent' (≥ 90 points) or 'Good' (80-89 points) clinical performance based on the Harris Hip Score (HHS) will be evaluated to demonstrate device efficacy. The HHS is a clinician-administered tool that quantitatively scores hip function across domains including pain, function, functional activities, absence of deformity, and range of motion (ROM), with a total score ranging from 0 (worst possible outcome) to 100 (best possible outcome).
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the signing of informed consent up to 24 months post-operatively.
Continuous monitoring, documentation, and cumulative tracking of the incidence and frequency of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study surveillance period, regardless of their causal relationship to the investigational revision medical device or surgical procedure. Events will be systematically classified by intensity/severity (mild, moderate, severe), outcome characteristics, and causality relationship pattern.
Incidence of Clinical Complications
Time frame: From the time of signing the informed consent form up to 24 months post-operatively.
Evaluation of the rate, frequency, and types of all clinical complications recorded throughout the study. This includes intraoperative complications captured retrospectively from surgical medical charts (such as femoral or acetabular perforation/fractures, vascular injuries, and nerve lesions including peroneal or sciatic nerve injuries) as well as longitudinal complications documented during the prospective follow-up phase (such as joint dislocation, aseptic loosening, implant failure/breakage, deep or superficial surgical site infections, and subsequent re-revision/reoperation rates) associated with the routine clinical utilization of the Tıpmed™ Revision Hip Prosthesis System.
1 secondary outcome
Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)
Time frame: Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared publicly due to the strict confidentiality requirements, personal data protection legislation (KVKK Law No.6698), and commercial intellectual property rights policies of the sponsor.
Related trials for Revision Hip Arthroplasty
Active, not recruiting
CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
Active, not recruitingObservational study
Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA
Advanced Degeneration of the Hip Joint, Revision of the Hip Joint
RecruitingPhase 4
ROADMAP Clinical Trial
Prosthetic Joint Infections of Hip, Prosthetic Joint Infections of Knee
RecruitingObservational study
Long-term Aseptic Revision & Advanced Hip Arthroplasty Database
Hip Arthropathy Associated With Other Conditions
RecruitingObservational study
Heidelberg Registry for Hip and Knee Joint Implants and Revisions
Osteoarthritis, Arthroplasty
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.
Ahmet Karakaşlı, Professor study director
Dokuz Eylul University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision Hip Arthroplasty and Aseptic Loosening of Prosthetic Joint, run by TIPMED Medical Device Manufacturing Ltd. Co. at 4 sites in Turkey (Türkiye).
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Onel, Sponsor Rep (+90 232 479 33 22, yaseminonel@tipmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Joint Performance via Harris Hip Score (HHS) at 24 Months (time frame: 24 months post-operatively). The study lists 3 primary outcomes in all. 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 18 Jun 2026.