Total Hip Arthroplasty (THA)NCT07651735
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
An observational study of Total Hip Arthroplasty (THA) and Hemiarthroplasty, 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™ Primary Hip Prosthesis System in adult subjects undergoing primary hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip
- What is being tested?
- Tipmed™ Primary Hip Prosthesis System
- Type of treatment
- Medical device
- How many people
- 101 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 12 Mar 2024to 31 Mar 2029
- Phase
- Observational
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 primary hip arthroplasty (either total or partial) at participating multi-center orthopedic clinics. The cohort specifically represents individuals whose surgical treatment involved the standard clinical implantation of the Tipmed™ Primary Hip Prosthesis System component options. Eligible individuals who are legally competent and provide written informed consent to allow their routine post-operative clinical, laboratory, and radiographic data to be documented will be consecutively enrolled.
Who may be able to join
- Individuals aged 18 years and older,
- Male or female participants,
- Subjects who have undergone Primary Hip Arthroplasty (either total or partial) for any indication,
- Subjects in whose surgical procedure the Tipmed™ Primary Hip Prosthesis System components were utilized.
- Subjects who are not legally restricted (e.g., military personnel, convicts, or individuals under legal guardianship).
- Subjects 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, 10700
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™ Primary 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™ Primary Hip Prosthesis System in adult subjects undergoing primary 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, observational, PMCF study evaluates the short-to-medium-term safety and efficacy data of the Tipmed™ Primary Hip Prosthesis System in patients undergoing primary hip arthroplasty (total or partial) across 4 clinical centers in Turkey. A total of 101 eligible participants will be enrolled in accordance with the pre-defined inclusion and exclusion criteria. Pre-operative demographic details, medical history, and surgical parameters will be captured retrospectively from patient medical charts. Following the baseline 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 indicators. Clinical performance and joint functionality 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 (such as dislocation, aseptic loosening, or infection), and hardware deficiencies. Radiological findings (implant orientation, migration, osteointegration) and laboratory indicators (such as C-Reactive Protein and Sedimentation Rate) will be documented when available as part of standard medical surveillance.
Demographic characteristics, clinical parameters, and efficacy/safety outcomes will be summarized using descriptive statistics. Stratified analyses will be conducted based on the specific type of primary surgical intervention. Separate subgroup analyses will be executed for study participants who undergo partial hip arthroplasty (hemiarthroplasty) to isolate and evaluate their outcomes independently from the patients treated with total hip arthroplasty. Categorical variables across these subgroups will be compared using the Chi-square test or Fisher's exact test, as appropriate.
- Conditions
- Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip, Femoral Neck Fractures, Joint Diseases
- Being tested
- Tipmed™ Primary Hip Prosthesis System
- Keywords
- Hip Prosthesis, Total Hip Prosthesis, Partial Hip Prosthesis, Primary Hip Arthroplasty, Post-Market Clinical Follow-Up (PMCF), Harris Hip Score (HHS)
- Medical subject headings
- Osteoarthritis, Femoral Neck Fractures, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tipmed™ Primary Hip Prosthesis SystemDevice
Post-market utilization of the commercially available Tipmed™ Primary Hip Prosthesis System during routine orthopedic care. Device components include various configurations such as cemented or uncemented stems (anatomic or square cross-section), acetabular cups, bipolar cups, and titanium metal shells fitted according to standard clinical routine and patient anatomy. No investigational or non-routine interventions are performed as part of this observational registry.
| Study group | Role | What they receive |
|---|---|---|
| Tipmed™ Primary Hip Prosthesis | A single prospective cohort of adult patients tracked during routine clinical practice who have undergone primary hip arthroplasty (either total hip arthroplasty or partial hemiarthroplasty) using the Tipmed™ Primary Hip Prosthesis System (including cemented or uncemented stem options based on standard surgical indications). Receives: Device: Tipmed™ Primary 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. 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 of all adverse events (AEs) and serious adverse events (SAEs) occurring throughout the study period, regardless of their causal relationship to the investigational medical device or surgical procedure. Events will be systematically classified by severity (mild, moderate, severe), outcome, and causality 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 complications recorded throughout the study period. This includes intraoperative complications captured retrospectively from surgical medical records (such as femoral or acetabular fractures, vascular injuries, and nerve lesions) as well as longitudinal complications documented during the follow-up phase (such as joint dislocation, aseptic loosening, implant breakage, or deep and superficial surgical site infections) associated with the routine clinical utilization of the Tipmed™ Primary 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 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 posted16 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 Total Hip Arthroplasty (THA)Studies 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
- 101 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
- NCT07651735
- Sponsor's protocol ID
- INFO TPMHIP P
- Other IDs
- 2023-190
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2026
- Last updated
- 16 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.