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Results from a first-in-human pilot clinical trial of Askel Healthcare’s COPLA cartilage implant showed that the primary endpoint was successfully met in all initial 10 patients. The trial also provided promising preliminary efficacy data.
The COPLA Cartilage implant is a novel biodegradable solution designed to surgically treat knee cartilage damage. A key differentiator of COPLA is its ability to allow immediate, unrestricted full weight-bearing post-surgery. This facilitates faster rehabilitation and a quicker return to activities, as were observed in the Pilot Trial.
Key findings from the pilot trial based on the interim report with the first 10 subjects at the six-month follow-up:
Safety: COPLA Cartilage implant is safe for use in humans with no implant-related complications reported.
Weight-Bearing: All patients achieved full and unrestricted weight-bearing immediately after surgery and maintained this ability throughout the first six months.
Clinical Improvements: Significant improvements in knee function and pain levels were observed over six months, with no pain medication needed from six weeks post-surgery onwards.
Recovery: Physiotherapist evaluations indicated good recovery, with knee movement improved and strength returning to pre-surgery levels within three months. All patients returned to their pre-injury activity levels between six weeks and three months, which was maintained at six months. Patients reported high satisfaction with the surgery, noting an overall improvement in their quality of life.
Ease of use: The implantation of COPLA was successful in all surgeries. Tailoring and placement of the implant to the lesion added on average 15 minutes to the length of surgery. No special instrumentation was needed.
The company will now turn its focus towards an upcoming Pivotal Trial, for which preparations are well underway. Meanwhile, the Pilot Trial will continue to be closely monitored, with key milestones including the one-year results from the first ten patients expected by the end of this year, followed by the 12- and 24-month results from all 20 patients.
The Pivotal Trial will aim to demonstrate the clinical benefits of COPLA in a randomized trial that is designed to show superiority over current surgical standard treatments and will serve as a cornerstone for market authorizations in the US and EU. Patient recruitment is scheduled to begin in the first half of 2025.
Source: Askel Healthcare
Results from a first-in-human pilot clinical trial of Askel Healthcare's COPLA cartilage implant showed that the primary endpoint was successfully met in all initial 10 patients. The trial also provided promising preliminary efficacy data.
The COPLA Cartilage implant is a novel biodegradable solution designed to surgically treat knee cartilage...
Results from a first-in-human pilot clinical trial of Askel Healthcare’s COPLA cartilage implant showed that the primary endpoint was successfully met in all initial 10 patients. The trial also provided promising preliminary efficacy data.
The COPLA Cartilage implant is a novel biodegradable solution designed to surgically treat knee cartilage damage. A key differentiator of COPLA is its ability to allow immediate, unrestricted full weight-bearing post-surgery. This facilitates faster rehabilitation and a quicker return to activities, as were observed in the Pilot Trial.
Key findings from the pilot trial based on the interim report with the first 10 subjects at the six-month follow-up:
Safety: COPLA Cartilage implant is safe for use in humans with no implant-related complications reported.
Weight-Bearing: All patients achieved full and unrestricted weight-bearing immediately after surgery and maintained this ability throughout the first six months.
Clinical Improvements: Significant improvements in knee function and pain levels were observed over six months, with no pain medication needed from six weeks post-surgery onwards.
Recovery: Physiotherapist evaluations indicated good recovery, with knee movement improved and strength returning to pre-surgery levels within three months. All patients returned to their pre-injury activity levels between six weeks and three months, which was maintained at six months. Patients reported high satisfaction with the surgery, noting an overall improvement in their quality of life.
Ease of use: The implantation of COPLA was successful in all surgeries. Tailoring and placement of the implant to the lesion added on average 15 minutes to the length of surgery. No special instrumentation was needed.
The company will now turn its focus towards an upcoming Pivotal Trial, for which preparations are well underway. Meanwhile, the Pilot Trial will continue to be closely monitored, with key milestones including the one-year results from the first ten patients expected by the end of this year, followed by the 12- and 24-month results from all 20 patients.
The Pivotal Trial will aim to demonstrate the clinical benefits of COPLA in a randomized trial that is designed to show superiority over current surgical standard treatments and will serve as a cornerstone for market authorizations in the US and EU. Patient recruitment is scheduled to begin in the first half of 2025.
Source: Askel Healthcare
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
