Retrospective Data Collection of Plantar Stabilization of Fusions of the 1st Tarsal-metatarsal joint with the ORTHOLOC™ 3Di- Plantar Lapidus Plate System T-I-097
- Conditions
- Only retrospective, data collection and analysis of patients whose medial foot instability or misalform of the foot was treated with a Plantar Lapidus Plate System .
- Registration Number
- DRKS00032427
- Lead Sponsor
- Stryker
- Brief Summary
Keyvords: Plantar Lapidus plate system, retrospective data study, X-ray results, clinical Outcomes, follow up 92% more than 6 months. Sumary The study was designed as a retrospective data study und performed June 23, 2023 to Novembre 23, 2023. Data from the first 100 cases that receive dan ORTHOLOC™ 3Di Plantar Lapidus plate system were fully evaluated. There were 11 male and 89 female patients. Mean age at time of surgery was 56.4 years (range: 21-82); almost half of the patients were over 69 years old (47%). The side distribution was fairly even with 49 right feet and 51 left feet. The Ortholoc™ 3Di Plantar Lapidus plate system with its fixation screws was implanted in 100% of the cases. A 4.5 mm DART-FIRE® cancellous tensile hollow screw was used for the lag screw. A hollow-tension cancellous bone screw with a washer was used for the intermetatarsal set screw, which was planned for removal and is therefore not an unexpected follow-up operation. At 6 weeks after surgery, 99 cases showed the correct position of the arthrodesis in X-rays, 100% showed the correct position of the implants. In 2 cases, a re-arthrodesis was performed using the same technique and used the ORTHOLOC™ 3Di Plantar Lapidus plate system again. These operations fell within the period of the study and were each evaluated as a new case; both healed in a timely and correct manner. There were 93 final x-ray examinations performed on the 100 cases in the study: 2 cases had re-arthrodesis procedures and 5 did not appear for a final examination. Of the 93 cases examined, 85 cases (91%) had stable implants and good or initial development of the arthrodesis at the intended end of the treatment period. The position of the arthrodesis was correct in all 92 cases (98.9%); in one case it was sufficient (1.1%). The position of the implants was correct in all cases (100%). This means that the goal of shaping was achieved in all cases with a final examination. All 93 cases that received a final examination were able to walk in street shoes; although, 15 needed a stiffened sole and a roll-off sole. As part of the final examination, each case received a questionnaire with questions about the operation procedure, anesthesia, follow-up treatment and overall result. An extensive evaluation of all answers is not useful for this study. Only the analysis of the result for the “overall assessment” by the cases is presented. This representation is used to estimate compliance and the subjective outcome of the cases. 82 of the 100 cases returned a completed and usable questionnaire. Of the 82, 25 (30%) rated their overall result as “very good”, 37 (45%) as “good”, 15 (18%) as “satisfactory”, 3 (3.7%) as sufficient and 1 each (1.2%) with “poor” and 1 (1.2%) with “unsatisfactory”. This means that 75% of the cases stated that they had a good or very good result and only around 2.5% rated their result as unsatisfactory or poor, just under 22% stated that they were satisfactory or sufficient. From this it can be concluded that the 75% of the cases of retrospective data collection are well satisfied with their functional outcome and the quality of life achieved, and 18% are sufficiently satisfied. There was no correlation between the bony healing of the arthrodesis and the evaluation. The “very good” ratings included one re-arthrodesis and several delayed bone healings. The poorest ratings were given for symptoms that still existed in the foot after the arthrodesis had healed in a timely manner, even if the symptoms were present months or years before the operation. All 4 cases of pain treatment in the area of arthrodesis had expressed the desire to remove the implant at an early stage. For complaints in the area of an implant that persist for 12 months despite physiotherapy and anti-inflammatory drugs, as well as a careful inspection of the shoes and insoles, we regularly offer implant removal. At the final follow-up evaluation (approximately 6 months post-operation), there were 17 cases with bone healing complications (Table 3). None were device-related. There were 6 nonunions (6.5%): 1 was treated surgically with re-arthrodesis and healed without symptoms. There were 9 delayed bone unions (9.7%): 6 of them healed conservatively and had an X-ray showing a completed arthrodesis and were free of symptoms, and 3 healed without symptoms, but did not yet have a closed arthrodesis gap on the X-ray, although the material was stable. There were 2 cases of mechanical destruction of the arthrodesis (i.e., dislocation) (2.2%) due to incorrect loading and lack of compliance. After re-arthrodesis, both healed in a timely and unobtrusive manner. In summary, of 17 abnormal bone healing processes, 3 healed following a revision surgery (3.2%) and 14 healed conservatively. This shows the performance of the ORTHOLOC™ 3Di Plantar Lapidus Plate System when used as intended by bone consolidation in the intended alignment in the cases evaluated and the safety of the system is proven based on the results obtained from the evaluation of the retrospective data collection. There were 5 cases of pain (5.4%) was reported at the final examination. 4 of these were addressed with an elective implant removal of the ORTHOLOC™ 3Di Plantar Lapidus Plate System (4.3%). There was another hardware removal of 1 fixation screw, which had slipped in the arthrodesis gap. In summary, of the 100 cases in this study, there were 8 follow-up operations, 3 revisions (3.2%) and 5 hardware removals (5.4%); although, only 4 were removal of the ORTHOLOC™ 3Di Plantar Lapidus Plate System (4.3%). This indicates good tolerability of the ORTHOLOC™ 3Di Plantar Lapidus Plate System and favorable placement with good soft tissue overage. Walsrode, January 24, 2024 Dr. med. Gerd Dieter von Koschitzky
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
A) Subjects who previously received the ORTHOLOC™ 3Di Plantar Lapidus Plate System in accordance with following legally cleared Indications for Use: for plantar stabilization of arthrodeses/fusions of the first tarsal-metatarsal joint (Lapidus procedure).
B) The operation was over a year ago.
C) All patients thad meet criteria A and B without gaps and have received a Lapidos Prcedure from the „Chirurgische Praxis Walsrode” beginning 2016.02.01.
Patients with Lapidus Procedure using a different stabilization system then the ORTHOLOC™ 3Di Plantar Lapidus Plate System .
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: Performance<br>Efficacy/performance of the System will be determined by bone consolidation in the intended alignment measured by radiographic assessment and the Investigator’s clinical determination of foot function.<br>
- Secondary Outcome Measures
Name Time Method Information on device-related Adverse Events will be gathered and analyzed by the Investigator.