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

NCT07651735 | Recruiting

• 2 other identifiers: INFO TPMHIP P2023-190
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Total Hip Arthroplasty (THA); Hemiarthroplasty; Osteoarthritis (OA) of the Hip; Femoral Neck Fractures; Joint Diseases

Keywords

Hip Prosthesis; Total Hip Prosthesis; Partial Hip Prosthesis; Primary Hip Arthroplasty; Post-Market Clinical Follow-Up (PMCF); Harris Hip Score (HHS)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Longitudinal Changes in Hip Functioning via Harris Hip Score (HHS)

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

Study Arms (1)

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

Interventions

Tipmed™ Primary Hip Prosthesis System DEVICE

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.

Tipmed™ Primary Hip Prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Subjects currently participating in any other interventional clinical trial.

Sponsors & Collaborators

• TIPMED Medical Device Manufacturing Ltd. Co.: lead

Study Sites (4)

Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Atatürk City Hospital

Balıkesir, 10100, Turkey (Türkiye)

RECRUITING

Republic of Turkey Ministry of Health, Balıkesir Provincial Health Directorate, Burhaniye State Hospital

Balıkesir, 10700, Turkey (Türkiye)

RECRUITING

Dokuz Eylül University Research and Application Hospital

Izmir, 35330, Turkey (Türkiye)

RECRUITING

Republic of Turkey Ministry of Health Izmir Provincial Health Directorate Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital

Izmir, 35390, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis; Femoral Neck Fractures; Joint Diseases

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Ahmet Karakaşlı, Professor

  Dokuz Eylul University

  STUDY DIRECTOR

Central Study Contacts

Yasemin Önel, Sponsor Rep

CONTACT

+90 232 479 33 22; yaseminonel@tipmed.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 16, 2026
• Study Start: March 12, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: June 16, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4)