Clinical Research Directory

Characteristics of Persistent Pain Composition Following Total Hip or Knee Arthroplasty: a Descriptive Study

Despite high success rates of hip and knee arthroplasty, up to 20% of patients report moderate-to-severe pain (NRS \> 3) persisting beyond the expected healing period. This investigator-initiated, descriptive cohort study will re-invite approximately 100 consenting patients with persistent postoperative pain-identified from a pool of \~7 000 respondents-to complete standardized assessments of neuropathic (DN4), nociplastic (IASP criteria + Fibromyalgia Survey Questionnaire) and nociceptive (KOOS/HOOS pain domains) pain. Primary outcomes are the prevalence of potential nociplastic pain and the proportion experiencing significant pain in two or more mechanistic categories. Secondary analyses will compare baseline vs. re-evaluated DN4 scores, FSQ and KOOS/HOOS distributions, and examine differences between patients with and without possible neuropathic pain. Findings will inform targeted pre- and postoperative pain management strategies.

Cognitive and Physical Recovery After Hip Fracture in Frail Patients Using Digital Rehabilitation Technology

The aim of this study is to evaluate whether integrating a technology-based rehabilitation approach with conventional therapies in the rehabilitation of patients with proximal femoral fracture may be advantageous compared with conventional therapy alone. Specifically, the objective is to assess whether the addition of technology-assisted rehabilitation can improve cognitive function, in addition to motor function and overall abilities, compared with conventional rehabilitation alone. Furthermore, the study intends to explore the feasibility of implementing technology-assisted rehabilitation as a stable and routine component of everyday clinical practice, also considering the perspective of healthcare professionals.

Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment. The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis. Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis. A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting. No previous clinical trial

Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip Arthroplasty

In 2022, data from the UK's National Joint Registry (NJR) and the American Joint Replacement Registry (AJRR) indicated that Total Hip Replacement (THR) is the most commonly performed orthopaedic joint surgery. The NJR has observed that between 10 and 20% of hip implants require revision within the first 10 years. The main reasons for these revisions include implant fractures, joint incompatibility, aseptic loosening, dislocation and wear of the polyethylene (PE) insert. To address this problem, highly cross-linked polyethylene (HXLPE) inserts have been developed. Cross-linking helps to limit wear on polyethylene prostheses in total hip arthroplasty. However, there are concerns about the loss of elasticity of HXLPE and oxidation after implantation. A new generation of inserts based on highly cross-linked polyethylene (irradiation dose ≥100 Kgy), enriched with vitamin E, has been developed. This PE, called ECIMA, was developed to maintain mechanical properties, minimise PE wear and improve long-term oxidation resistance. In the HAS evaluation report on highly cross-linked polyethylene inserts dated 24 January 2023, data from the literature show less wear of highly cross-linked polyethylene compared to conventional polyethylene. Nevertheless, the use of highly cross-linked polyethylene is not yet the gold standard. Furthermore, the data in the literature mainly concern single-mobility cups but not double-mobility cups. Finally, new imaging protocols now make it possible to assess the wear of prosthesis materials more accurately. In this context, it seems appropriate to conduct a French study comparing double-mobility cups containing highly cross-linked polyethylene or conventional polyethylene inserts.

Comparison of Pericapsular Nerve Group (PENG) Block With a Combined Femoral, Sciatic, Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia in Secondary Total Hip Arthroplasty; (REVPET)

The aim of this clinical trial is to compare the analgesic effect of a pericapsular nerve group (PENG) block with a combined femoral, sciatic, lateral femoral cutaneous nerve block for postoperative analgesia in patients scheduled for secondary total hip arthroplasty. The primary objective of this study is to compare postoperative pain management between the PENG block and the combined block (femoral, sciatic, lateral femoral cutaneous) by measuring postoperative morphine consumption in each of the two groups. Participants will be randomized into two groups. Patients assigned to the PENG group will receive a PENG block with ropivacaine, followed by a sham (sciatic) block, and spinal anesthesia with isobaric bupivacaine. Patients assigned to the combined block group will receive femoral, sciatic, lateral femoral cutaneous nerve blocks with ropivacaine, followed by spinal anesthesia with isobaric bupivacaine.

Changes in Perioperative Blood Volume and Fluid Distribution in Patients Undergoing Primary Total Hip Replacement.

Clinical assessment of bleeding and calculation of perioperative blood loss do not provide an accurate estimate of blood volume. This makes rational fluid management difficult, which is of high importance for patient-related outcomes. The availability of carbon monoxide(CO)-rebreathing allows for simple, non-invasive and precise measurement of changes in blood volume. The purpose of the study is to investigate and describe changes in blood volume and fluid distribution perioperative in patients undergoing total hip arthroplasty. Furthermore, to investigate the association between changes in blood volume and incidence of orthostatic insufficiency.

Cephalic Femoral Heads Follow Up

Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of cephalic femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with cephalic femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.