Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System

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.

Study Overview

• Status: Recruiting
• Conditions: Joint Diseases; Hemiarthroplasty; Femoral Neck Fractures; Total Hip Arthroplasty (THA); Osteoarthritis (OA) of the Hip
• Intervention / Treatment: Device: Tipmed™ Primary Hip Prosthesis System

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.

• Study Type: Observational
• Enrollment (Estimated): 101

Contacts and Locations

• Study Contact: Name: Yasemin Önel, Sponsor Rep; Phone Number: +90 232 479 33 22; Email: yaseminonel@tipmed.com

Study Locations

• Turkey (Türkiye)
  • Balıkesir, Turkey (Türkiye), 10100
    • Recruiting
    • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital
    • Contact: Özgün Karakuş, Professor; Phone Number: +90 266 460 4000; Email: ozgunkarakus@hotmail.com
    • Principal Investigator: Özgün Karakuş, Professor
    • Sub-Investigator: fatih Işık, MD, Spec.
    • Sub-Investigator: Fatih Palıt, MD, Spec.
    • Sub-Investigator: Uğur Yüzügüldü, MD, Spec.
    • Sub-Investigator: Mücahit Çelik, MD, Spec.
  • Balıkesir, Turkey (Türkiye), 10700
    • Recruiting
    • Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital
    • Contact: Cemal Aydın, MD, Spec.; Phone Number: +90 266 412 6999; Email: cemalaydın80@hotmail.com
    • Principal Investigator: Cemal Aydın, MD, Spec.
  • Izmir, Turkey (Türkiye), 35330
    • Recruiting
    • Dokuz Eylül University Research and Application Hospital
    • Contact: Ahmet Karakaşlı, Professor; Phone Number: +90 (232) 412 22 22; Email: karakasliahmet@gmail.com
    • Principal Investigator: Ahmet Karakaşlı, Professor
  • Izmir, Turkey (Türkiye), 35390
    • Recruiting
    • Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital
    • Contact: Kamil Yamak, Professor; Phone Number: +90 532 722 0852; Email: kamilyamak@hotmail.com
    • Principal Investigator: Kamil Yamak, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Subjects currently participating in any other interventional clinical trial.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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).

Device: Tipmed™ Primary Hip Prosthesis System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	From the time of signing the informed consent form up to 24 months post-operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Retrospective pre-operative baseline, and prospective assessments at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively.

Collaborators and Investigators

• Sponsor: TIPMED Medical Device Manufacturing Ltd. Co.
• Investigators: Study Director: Ahmet Karakaşlı, Professor, Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hip Prosthesis; Total Hip Prosthesis; Primary Hip Arthroplasty; Post-Market Clinical Follow-Up (PMCF); Partial Hip Prosthesis; Harris Hip Score (HHS)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Arthritis; Rheumatic Diseases; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Joint Diseases; Osteoarthritis; Femoral Neck Fractures
• Other Study ID Numbers: INFO TPMHIP P; 2023-190 (Other Identifier: Turkish Medicines and Medical Devices Agency (TITCK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No